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Sandoz receives US FDA approval for biosimilar Hyrimoz® high-concentration formulation

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Sandoz receives US FDA approval for biosimilar Hyrimoz® high-concentration formulation

March 21, 2023: “Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz) injection.

The adalimumab citrate-free HCF (100 mg/mL) is approved to treat seven indications covered by the reference medicine, Humira®* (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.1

Sandoz intends to launch the Hyrimoz citrate-free HCF in the US on July 1, 2023.

“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” said Keren Haruvi, President, Sandoz Inc., Head of North America.

“Sandoz has more than two decades of experience researching, developing and bringing biosimilars to markets across the globe. We are excited to continue this leadership by providing patients with another treatment option to help manage their chronic conditions.”

The FDA approval was based on a Phase I pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL (HCF).

This study met all of the primary objectives, demonstrating comparable PK and showing similar safety and immunogenicity of the adalimumab 50 mg/mL and adalimumab HCF.

“Biosimilars are extensively studied, FDA-approved treatments,” said Steve Taylor, president and chief executive officer, Arthritis Foundation. “There are millions of patients affected by chronic inflammatory conditions that drastically impact their everyday lives.

Given the high burden of disease for these conditions, biosimilars are one potential solution for healthcare providers and patients to consider, to ensure patients can take and stay on their medicines to help manage their disease and health outcomes.”

The FDA approval of Hyrimoz HCF builds on the already approved and well-established Sandoz global biosimilar portfolio in immunology. Sandoz has nearly 120 million days of patient experience with Hyrimoz across 40 countries.

When it launches, Hyrimoz HCF will represent the first launch of a Sandoz biosimilar in the US market in this specific disease space.

Sandoz is committed to helping millions of patients sustainably and affordably access critical and potentially life-changing biologic medicines across a range of areas including immunology, oncology, supportive care and endocrinology.

Sandoz has a leading global portfolio with eight marketed biosimilars and a further 15+ in various stages of development.

Since launching the first biosimilar in the US in 2015, Sandoz has proven biosimilars create early and expanded patient access to life-altering medicines while increasing healthcare savings and creating competition that fuels innovation and development of new and enhanced treatments in areas of unmet need.

About Hyrimoz® (adalimumab-adaz)
Adalimumab, the active ingredient in Hyrimoz, is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions — including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis — causing inflammation and tissue destruction in joints, mucosa or skin.

In some cases of autoimmune disease, the immune system damages the body’s own tissues. Hyrimoz targets and blocks the protein that contributes to disease symptoms.”

https://www.novartis.com/news/media-releases/sandoz-receives-us-fda-approval-biosimilar-hyrimoz-adalimumab-adaz-high-concentration-formulation

Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma

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Calquence granted first regulatory approval in China for adults with previously treated mantle cell lymphoma

March 23, 2023: “AstraZeneca’s Calquence (acalabrutinib), a next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor, has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

This is the first approved indication for Calquence in China.

The conditional approval by the National Medical Products Administration (NMPA) was based on positive results from two clinical trials, including the ACE-LY-004 global Phase II trial in adults with relapsed or refractory MCL and a Phase I/ II trial in Chinese patients with relapsed or refractory MCL and other B-cell malignancies.

Continued approval for this indication may be contingent upon verification of ongoing randomised controlled confirmatory trials.

MCL is typically an aggressive, rare form of non-Hodgkin lymphoma (NHL) that accounts for between 2-6% of all patients diagnosed with NHL in China. Patients are generally diagnosed around 60 years of age, often at later stages of the disease.

Jun Zhu, Chief Physician, Department of Lymphatic Oncology, Peking University Cancer Hospital, Beijing, said: “Mantle cell lymphoma progresses rapidly and responds poorly to conventional treatment such as immunochemotherapy. 

Before the emergence of BTK inhibitors, there were few satisfactory treatment options for patients. 

The next-generation BTK inhibitor Calquence has higher target selectivity, fewer side effects, and a higher response rate compared to currently available treatments. This approval of Calquence in China can provide a new treatment option which can better benefit patients with this disease.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval for Calquence offers people living with mantle cell lymphoma in China an effective and tolerable new treatment option to help control their disease.

As the first approval in China for Calquence, it is also an exciting step forward for AstraZeneca in blood cancers, enabling us to help more patients across the globe gain access to innovative treatments.”

Results from the ACE-LY-004 Phase II trial showed at a median follow up of 15.2 months, investigator-assessed overall response rate (ORR) with Calquence was 80.6% (95% confidence interval [CI] 72.6-87.2), with a complete response (CR) achieved in 39.5% of patients with relapsed or refractory MCL (95% CI 30.9-48.7).

Longer-term follow-up data showed at 38.1 months, patients treated with Calquence remained progression-free for a median of 22 months, with median overall survival (OS) of 59.2 months (95% CI 36.5-NE).

Additionally, results from a Phase I/II trial conducted in China showed Calquence achieved a 82.4% ORR, with a CR achieved in 35.3% of patients with MCL based on a blinded independent central-review (BICR) analysis (95% CI 65.5-93.2). 

Calquence reduced the risk of disease progression or death by 51.5% (95% CI 33.3-67.0) at 12 months, with an estimated duration of response (DOR) of 65.5% (95% CI 66.6-93.3). The median DOR was not reached.2

The safety and tolerability of Calquence in these trials was consistent with that observed in previous clinical trials.

Calquence is approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the US and Japan and is approved for the treatment of CLL in the EU and in several other countries worldwide in the treatment-naïve and relapsed or refractory settings. 

Calquence is also approved in the US and several other countries for the treatment of adult patients with MCL who have received at least one prior therapy. 

Calquence is not currently approved for the treatment of MCL in Japan or the EU.”

https://www.astrazeneca.com/media-centre/press-releases/2023/calquence-granted-first-regulatory-approval-in-china-for-adults-with-previously-treated-mantle-cell-lymphoma.html

Bayer’s Nubeqa™ approved for additional prostate cancer indication in China

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Bayer’s Nubeqa™ approved for additional prostate cancer indication in China

March20,2023: “The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Nubeqa is already approved in China for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

“Prostate cancer cases in China have increased significantly in recent years. Compounding that, nearly a third of patients who are newly diagnosed will have metastatic disease.

We are therefore delighted that patients in China will now have a new treatment option for metastatic hormone-sensitive prostate cancer that delays disease progression, extends survival and maintains quality of life”, said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of the Oncology SBU at Bayer.

“Bayer is committed to improving health outcomes for people living with prostate cancerand that as many eligible patients as possible gain access to Nubeqa.”

The approval is based on the positive results from the Phase III ARASENS trial, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel, in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms. These results were published in The New England Journal of Medicine.

Darolutamide is being investigated in a broad development program with three additional ongoing or planned large clinical studies, to evaluate its potential across prostate cancer patients from early- to late-stage disease.

This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

Nubeqa has been developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

About the ARASENS Trial
The ARASENS trial is the only randomized, Phase III, multi-center, double-blind, trial which was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi), darolutamide, plus ADT in combination with docetaxel to ADT plus docetaxel (a guideline recommended standard-of-care) in metastatic hormone-sensitive prostate cancer (mHSPC).

A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of darolutamide twice a day or matching placebo, plus ADT in combination with docetaxel.

The primary endpoint of this trial was overall survival (OS). Secondary endpoints included time to castration-resistant prostate cancer (CRPC), time to pain progression, time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all evaluated at 12‐week intervals, as well as adverse events (AEs) as a measure of safety and tolerability. Results from this trial were published in the New England Journal of Medicine.

A plain language summary publication of these data was published in Future Oncology. The ARASENS trial demonstrated that darolutamide plus ADT in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel alone.

Improvements in the secondary endpoints supported the benefit observed in the primary endpoint, overall survival.1

About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy.

Upon relapse, when the disease will metastasize or spread, or if the disease is newly diagnosed, but has already spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment.

Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of ADT and docetaxel.

Despite these treatments, a large proportion of men with mHSPC will eventually experience progression to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.


About Nubeqa™ (darolutamide)
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells.

The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans.

This is supported by the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial and the improved verbal learning and memory observed in the darolutamide arm of the Phase II ODENZA trial.

Nubeqa is approved in more than 80 countries around the world for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).

It is also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in a number of markets including the U.S., Japan, EU and China. Filings in other regions are underway or planned.

Bayer believes that the peak sales potential for Nubeqa may exceed €3 billion.

The compound is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov.

In addition, a study to explore the potential of darolutamide in the early setting for patients who have experienced a rise in their prostate specific antigen (PSA) levels following surgery or radiation, is also planned.

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments.

The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer.

Prostate cancer is the second most commonly diagnosed cancer in men3 and a key area of focus for Bayer.

The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development, including a unique approach of advancing targeted alpha therapies.

Bayer is focused on addressing the unique needs of prostate cancer patients, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue their everyday activities, so that they can live longer, better lives.”

https://www.bayer.com/media/en-us/nubeqa-darolutamide-approved-for-additional-prostate-cancer-indication-in-china/

FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

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FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

March 17, 2023: “The U.S. FDA issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.

The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2.

The company must not market or distribute these products in the U.S. or they risk FDA enforcement action.

The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. 

The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.

After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Specifically, evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.

“The FDA is a data driven agency and science remains the cornerstone of our tobacco product regulatory activities,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products.

“The science has guided – and will always guide – the FDA’s decision making on premarket tobacco product applications, including today’s marketing denial orders.”   

Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), shows that non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use.

In contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk.

Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes.

NYTS data also found Vuse to be the second most common brand youth e-cigarette users reported “usually” using.

These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement.

In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers.

Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory. 

Today’s actions are just one of many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency.

To date, the agency has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S.; this includes the Vuse Solo e-cigarette device and two accompanying tobacco-flavored e-liquid cartridges.

The FDA has also denied marketing applications for millions of products that did not meet the requirements in the law, including ten non-tobacco-flavored e-liquid cartridges under the Vuse Solo brand, Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.”

https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-two-vuse-solo-menthol-e-cigarette-products

Pfizer’s XTANDI® plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer

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Pfizer’s XTANDI® plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer

March 16, 2023: “Pfizer Inc. and Astellas Pharma Inc. announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).

Patients enrolled in the trial were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy.

The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide.

At the time of the analysis, a positive trend in the key secondary endpoint of overall survival (OS) was also observed, but these data were not yet mature. Patients in the trial will be followed for a subsequent final OS analysis.

The study also met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI monotherapy versus placebo plus leuprolide.

Additional key secondary endpoints reached statistical significance, including time to prostate-specific antigen (PSA) progression and time to first use of new antineoplastic therapy.

Other secondary endpoints are being analyzed. No new safety signals have been observed to date in the preliminary safety analysis, which is consistent with the established safety profile of XTANDI.

“As the only novel hormone therapy approved for three disease states of prostate cancer in the U.S., XTANDI has impacted hundreds of thousands of men,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development.

“The topline findings from EMBARK are highly encouraging and we look forward to engaging with health authorities to potentially bring XTANDI to men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence.”

“While current treatment options for localized prostate cancer are intended to be curative, some men remain at higher risk for biochemical recurrence following primary treatment, which may result in metastases,” said Ahsan Arozullah, M.D., MPH, Senior Vice President and Head of Development Therapeutic Areas, Astellas.

“The EMBARK trial is the first study to demonstrate a statistically significant improvement in MFS using the combination of XTANDI plus leuprolide in men with this stage of disease.”

Detailed results from EMBARK will be presented at a future medical meeting.

These data will also be discussed with regulatory authorities, including the U.S. Food and Drug Administration (FDA), to support a potential regulatory submission for XTANDI in this indication.

About EMBARK
The Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) at sites in the United States, Canada, Europe, South America, and the Asia-Pacific region.

Patients who were considered high-risk BCR had a prostate-specific antigen (PSA) doubling time ≤ 9 months, serum testosterone ≥ 150 ng/dL (5.2 nmol/L), and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer.

Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide, enzalutamide 160 mg as a monotherapy, or placebo plus leuprolide. 

The primary endpoint of the trial was metastasis-free survival (MFS) for enzalutamide plus leuprolide and placebo plus leuprolide.

MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death.

For more information on the EMBARK (NCT02319837) trial go to www.clinicaltrials.gov. 

XTANDI has not been approved for the treatment of patients with nmHSPC with high-risk BCR.

About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence  
Non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) means there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels.

Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years.

About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of the recurrence.

The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA doubling time ≤ 9 months.

High-risk BCR patients with a PSA doubling time of ≤ 9 months have a higher risk of metastases and death.

About XTANDI® (enzalutamide)
XTANDI (enzalutamide) is an androgen receptor signaling inhibitor.

The recommended dosage of XTANDI is 160 mg (capsules or tablets) administered orally once daily with or without food.

XTANDI is a standard of care that has received regulatory approvals for use in men with mHSPC, mCRPC, and nmCRPC in the United States and for one or more of these indications in more than 100 countries, including the European Union and Japan. More than 720,000 patients have been treated with XTANDI globally.”

https://www.pfizer.com/news/press-release/press-release-detail/phase-3-study-shows-xtandir-enzalutamide-plus-leuprolide

FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

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FDA Denies Marketing of Two Vuse Solo Menthol E-Cigarette Products

March 17, 2023: “The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.

The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2.

The company must not market or distribute these products in the U.S. or they risk FDA enforcement action. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. 

The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.

After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Specifically, evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.

“The FDA is a data driven agency and science remains the cornerstone of our tobacco product regulatory activities,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products.

“The science has guided – and will always guide – the FDA’s decision making on premarket tobacco product applications, including today’s marketing denial orders.”   

Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), shows that non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use.

In contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk.

Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes. NYTS data also found Vuse to be the second most common brand youth e-cigarette users reported “usually” using.

These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement.

In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers.

Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory. 

Today’s actions are just one of many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency.

To date, the agency has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S.; this includes the Vuse Solo e-cigarette device and two accompanying tobacco-flavored e-liquid cartridges.

The FDA has also denied marketing applications for millions of products that did not meet the requirements in the law, including ten non-tobacco-flavored e-liquid cartridges under the Vuse Solo brand, Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.”

https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-two-vuse-solo-menthol-e-cigarette-products

Bristol Myers Squibb Announces Progress Toward Long-Term Inclusion & Diversity Goals and Health Equity Commitments

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Bristol Myers Squibb Announces Progress Toward Long-Term Inclusion & Diversity Goals and Health Equity Commitments

March 15, 2023: ” Bristol Myers Squibb announced meaningful progress toward its global inclusion & diversity goals and health equity commitments, meeting and exceeding some goals ahead of schedule.

In 2020, Bristol Myers Squibb (BMS) and the Bristol Myers Squibb Foundation, an independent charitable organization, each committed $150 million over five years, totaling $300 million to address health equity efforts by 2025.

BMS and the Foundation are on track to achieve many of their respective goals and have exceeded some ahead of schedule. Progress against the four priority areas include:

  • Health Equity: BMS has made measurable progress against its goal to award $150 million to address health disparities. Nearly $100 million in distributed funding has reached more than 10 million people through programs and services.
    BMS is announcing $10 million in grants during 2023 to 17 U.S. organizations focused on addressing social determinants of health, including healthcare access and literacy to help close gaps and increase access to healthcare.
  • Increasing clinical trial diversity: In less than two years, more than half— 58%— of BMS’ clinical trial sites are now located in racially and ethnically diverse areas.
    This surpasses BMS’ initial goal of 25%.
    By embedding more clinical trial sites in diverse communities, BMS is helping enroll clinical trial populations that are more reflective of the broader patient populations and aligned with the epidemiology of the diseases we study.
  • Diversifying suppliers: BMS achieved its goal of spending $1 billion globally with diverse-owned businesses that create jobs and generate positive economic impact in diverse communities ahead of plan.
    This is against the company’s original goal to reach $1 billion in spending globally with diverse-owned businesses by 2025.
    Sustaining and building on this achievement will remain a priority. Investing in diverse suppliers enables BMS to close economic and healthcare gaps in diverse communities.
  • Diversifying company workforce: BMS has also made meaningful progress against the aspirational workforce representation goals announced in 2020, including the following:
    • More than doubled Black/African American executive (Vice President and above, VP+) representation in the U.S. to 6.1% from 3%, just exceeding the goal of reaching 6% by 2022
    • Increased the representation of global female executives (VP+) from 38.9% to 48.7%, nearly a 10% increase in two years, just below the goal of 50% by 2022
    • Increased the representation of Hispanic/Latino executives (VP+) in the U.S. from 3.7% to 6.1%, just below goal of 7.4% by 2022

BMS is announcing new aspirational workforce representation goals for Executive Directors and above (ED+) to strengthen our internal pipeline of talent and the next generation of leadership at BMS. These goals include:

  • Increase the representation of African/American Black leaders at the Executive Director level and above in the U.S. to 10% by end of 2025
  • Increase the representation of Hispanic/Latino leaders at Executive Director level and above in the U.S. to 11% by end of 2025

BMS achieved gender parity in the overall workforce population in 2015 and is close to achieving gender parity at the executive levels.

Although BMS is not establishing forward-looking representation goals for employees who are female, Asian American and Pacific Islander, or employees that represent additional dimensions of diversity at this time, the company remains fully committed to the development, advancement and engagement of these groups.

BMS believes this approach enables the company to engage a broader set of experiences, backgrounds and perspectives to drive equitable outcomes for all.

“Inclusion, diversity and health equity are not just our values; they are a critical driver of business performance with accountability owned by everyone,” said Giovanni Caforio, M.D., Chairman of the Board and Chief Executive Officer, Bristol Myers Squibb.

“Our expanded goals will enable us to drive a greater impact and build a more equitable future for our patients, colleagues, communities and industry.”

“Our global inclusion, diversity and health equity goals are accelerating our progress towards integrating inclusive practices into processes, policies and systems to ensure we are addressing the root causes of inequity,” said Pamela Fisher Chief Inclusion and Diversity Officer, Bristol Myers Squibb.

As part of the company’s health disparity commitments, the additional nearly $10 million in health equity grants will be dispersed among 17 U.S. nonprofit organizations in 2023.

These organizations address social determinants of health across BMS’ key therapeutic areas, cardiovascular disease, hematology, oncology and immunology.

These grants support various organizations working to improve health in the U.S. These organizations are developing and implementing innovative approaches and partnerships for addressing social determinants of health and integrating social care and healthcare to reduce health disparities.

The Foundation has also made significant progress against its goal to award $150 million to address health equity through a three-pronged approach.

The Winn Award Program, established by the Foundation with a $100 million commitment, is currently training 114 early-stage investigator physicians, and it has provided an immersive experience in community-based clinical research to 44 medical students who will support the goals of advancing clinical research in underserved patient communities.

The Foundation has awarded $45 million supporting thirty-two grants to advance health equity in cancer, cardiovascular disease, and immunology.

The Foundation has also mobilized approximately $1 million in employee donations supporting social justice organizations.”

https://news.bms.com/news/philanthropy/2023/Bristol-Myers-Squibb-Announces-Progress-Toward-Long-Term-Inclusion–Diversity-Goals-and-Health-Equity-Commitments/default.aspx

FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product

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FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product

March 16, 2023: “The U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified risk tobacco product (MRTP).

Copenhagen’s moist snuff smokeless tobacco product is a pre-existing tobacco product that has been marketed in the U.S. for years without modified risk information.

Today’s action now allows the product to be marketed as a modified risk product with the claim: “IF YOU SMOKE, CONSIDER THIS: Switching completely to this product from cigarettes reduces risk of lung cancer.”

“No tobacco product is safe or ‘FDA approved,’ so those who do not use tobacco products shouldn’t start,” said Brian King, Ph.D., M.P.H. “But tobacco products do exist on a spectrum of risk, with those that are smoked having the greatest risk.

In this case, the FDA’s scientific review found that if an adult smoker completely switched from cigarettes to this smokeless product, it would reduce their risk of getting lung cancer.” 

After a rigorous review of the available evidence, including recommendations from the Tobacco Products Scientific Advisory Committee, public comments, and other available scientific information, the FDA concluded that the specific claim related to lung cancer risk is scientifically accurate with respect to Copenhagen Classic Snuff.

The data show if current smokers switch completely from cigarettes to this product, they would reduce their risk of getting lung cancer.

The review also found those public health gains are not expected to be offset by nonusers starting to use this product. 

The risk modification order granted by the agency does not permit the company to market the product with any other modified risk claims—including those related to any other outcomes besides lung cancer risk—or statements that convey or could mislead consumers into believing that the product is endorsed or approved by the FDA, or that the FDA deems the product to be safe for use by consumers. 

The company is required to conduct postmarket surveillance and studies that include an assessment of product users’ behavior, understanding, and any previous use of cigarettes, as well as a scientific model to assess continued impact on population health. 

This modified risk granted order will expire in five years; the company must request and receive FDA authorization to continue marketing the product as a modified risk product.

If at any point the agency determines that the order no longer benefits the public health, the agency must withdraw the order.  

“The ball is now in the company’s court to conduct postmarket studies and surveillance on consumer impact, and to submit this information to FDA annually,” said Dr. King.

“If scientific evidence indicates that the net gains of these products no longer outweigh the risks at the population level—or if the company fails to conduct the required postmarket surveillance and studies—the FDA is committed to taking action as appropriate, including withdrawing the order, to protect public health.”

The MRTP process outlined in the 2009 Family Smoking Prevention and Tobacco Control Act allows companies to submit applications for the FDA to evaluate whether a tobacco product may be sold or distributed for use to reduce harm or the risk of tobacco-related disease.

By law, the FDA must also ensure that the advertising and labeling of modified risk products enables the public to understand the modified risk or modified exposure information and to understand the significance that information has in the context of total health and in relation to all tobacco-related diseases and health conditions.”

https://www.fda.gov/news-events/press-announcements/fda-authorizes-copenhagen-classic-snuff-be-marketed-modified-risk-tobacco-product

Sanofi to acquire Provention Bio, adding to portfolio TZIELD for type diabetes (T1D)

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Sanofi to acquire Provention Bio, adding to portfolio TZIELD for type diabetes (T1D)

March 13, 2023: “Sanofi and Provention Bio, Inc., a U.S.-based, publicly traded biopharmaceutical company focused on intercepting and preventing immune-mediated diseases including type 1 diabetes (T1D), have entered into an agreement under which Sanofi has agreed to acquire Provention Bio, Inc., for $25.00 per share in cash, representing an equity value of approximately $2.9 billion.

The transaction adds an innovative, fully owned, first-in-class therapy in type 1 diabetes to Sanofi’s core asset portfolio in General Medicines and further drives its strategic shift toward products with a differentiated profile.

TZIELD (teplizumab-mzwv) was approved in the U.S. last year as the first and only therapy to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

The acquisition is a strategic fit for Sanofi at the intersection of the company’s growth in immune-mediated diseases and disease-modifying therapies in areas of high unmet need, and its expertise in diabetes.

Sanofi will continue to utilize its capabilities in diabetes to maximize TZIELD’s potential as a transformative therapy globally and in the U.S., aiming to delay the onset of Stage 3 type 1 diabetes for some of the approximately 65,000 people diagnosed every year.

The purchase builds on an existing co-promotion agreement with Provention Bio that is already delivering TZIELD to patients in need of this immune-mediated therapy.

Olivier Charmeil
Executive Vice President, General Medicines, Sanofi
“The acquisition of Provention Bio builds on Sanofi’s mission to deliver best- and first-in-class medicines and resonates with our purpose of chasing the miracles of science for the benefit of people.

By coupling Provention Bio’s transformative innovation with Sanofi’s expertise, we aim to bring life-changing benefits to people at risk of developing Stage 3 type 1 diabetes.

Any additional indications, approvals and pipeline assets only serve to further our excitement. Given our existing partnership and complementary work in the diabetes and immunology spaces, we foresee a seamless integration and execution.”

TZIELD: First and only treatment indicated to delay onset of Stage 3 T1D

TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

Stage 3 T1D is associated with significant health risks, including diabetic ketoacidosis, which can be life threatening, and patients who progress to Stage 3 T1D eventually require insulin injections for life.

TZIELD is also in late-stage clinical development for the treatment of pediatric and adolescent patients that are newly diagnosed with clinical T1D (Stage 3).

A Phase 3 trial, PROTECT, is currently underway and top line results are expected in the second half of 2023. Additional opportunities for TZIELD include re-dosing and formulations as well as new therapeutic indications.

Ashleigh Palmer
Chief Executive Officer and Co-Founder, Provention Bio, Inc.
“Sanofi and Provention Bio share a common vision of bringing new therapies to patients with autoimmune diseases.

Under our co-promotion agreement, our companies have made significant progress educating healthcare providers and increasing patient access during the initial U.S. commercial launch of TZIELD.

Sanofi’s global expertise and commitment to immunology makes them an ideal acquiror and positions our innovative therapy to reach more patients as quickly as possible.”

Provention Bio also brings certain pipeline assets in early development in immune-mediated diseases.

Transaction Terms

Under the terms of the merger agreement, Sanofi will commence a cash tender offer to acquire all outstanding shares of Provention Bio, Inc. for $25.00 per share in cash, reflecting a total equity value of approximately $2.9 billion.

The consummation of the tender offer is subject to customary closing conditions, including the tender of a number of shares of Provention Bio, Inc. common stock, that together with shares already owned by Sanofi or its affiliates, represents at least a majority of the outstanding shares of Provention Bio, Inc. common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions.

If the tender offer is successfully completed, then following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Provention Bio, Inc., and all of the outstanding Provention Bio, Inc. shares that are not tendered in the tender offer will be converted into the right to receive the same $25.00 per share in cash offered to Provention Bio, Inc. shareholders in the tender offer.

Sanofi plans to fund the transaction with available cash resources. Subject to the satisfaction or waiver of customary closing conditions, Sanofi currently expects to complete the acquisition in the second quarter of 2023.

PJT Partners is acting as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP is acting as its legal counsel. BofA Securities, Inc. and Centerview Partners LLC are acting as financial advisors to Provention Bio, Inc. and Ropes & Gray LLP is acting as its legal counsel.”

https://www.sanofi.com/en/media-room/press-releases/2023/2023-03-13-06-00-00-2625367

LEO Pharma and ICON enter a Strategic Partnership on clinical trial mission

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LEO Pharma and ICON enter a Strategic Partnership on clinical trial mission

March 10, 2023: “LEO Pharma, a global leader in medical dermatology, and ICON plc announced a strategic partnership that will enable LEO Pharma to scale clinical trial execution that is patient-centric and cost effective, and which will support the company’s overall ambition of building one of the most effective and efficient clinical portfolio execution organisations in the industry. 


The mission of the partnership is to improve the lives of dermatology patients with access to innovative clinical trials and the launch of new medicines. The partnership will operate under the acronym of PACE, reflecting the requirement to move quickly to address today’s clinical development challenges. 

It also represents LEO Pharma and ICON’s shared values of Passion, Agility, Communication and Excellence in delivery. 


Building on earlier collaboration successes within psoriasis trials, LEO Pharma expect to further strengthen its transformation journey by entering a strategic partnership with ICON.

The partnership will leverage both fully outsourced and functional outsourcing models in a tailored and flexible hybrid approach.  LEO Pharma plans to achieve the following while remaining a patient centric company: 

  • Drive efficiencies in clinical trials  
  • Significant and lean scalability in all areas of expertise within clinical development  
  • Co-investment within the area of decentralised clinical trials  
  • Access to a significant number of ICON in-house ancillary services  
  • Economies of scope and scale  
  • Access to external data, knowledge & expertise as well as technologies
  • A partnership with a company that shares similar core values  


“We’ve been exploring several outsourcing models but found a hybrid sourcing model to be the most efficient.

Partnering with ICON supports our 2030 strategy as it will help us to bring innovative treatments to patients faster while also supporting a more sustainable business through scalability and flexibility,” said Jörg Möller, Executive Vice President and head of Global R&D at LEO Pharma. 

“ICON’s wealth of services and leading position in clinical development will support LEO Pharma’s R&D strategy building on driving innovation through partnerships and support staying competitive.”


In supporting LEO Pharma through this partnership, ICON will draw upon a team of over 500 professionals from across its business to deliver tailored solutions, bringing differentiating and enabling capabilities including its laboratories, Accellacare site-network, FIRECREST site management and decentralised clinical trial capabilities to create strategic advantage in how the trials are delivered. 

“ICON is delighted to enter this partnership with LEO Pharma that truly takes advantage of our breadth of capability and expertise.

We take a flexible and integrated approach when working with our partners, utilising fully outsourced, hybrid and FSP models that complement our partner’s internal capabilities and enable them to achieve their strategic goals.

It is also motivating for our employees to be working with a partner that shares our values and has a commitment to improving the lives of patients,” said Steve Cutler, CEO, ICON.”

https://www.leo-pharma.com/media-center/news/leo-pharma-and-icon-enter-a-strategic-partnership

AstraZeneca launches call for entries to 2023 global R&D Postdoctoral Challenge

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AstraZeneca launches call for entries to 2023 global R&D Postdoctoral Challenge

March 10, 2023: “AstraZeneca has announced the launch of the 2023 R&D Postdoctoral Challenge, an initiative designed to accelerate ideas to transform the treatment of some of the world’s most complex diseases.

The R&D Postdoctoral Challenge has been designed to drive R&D productivity, promote diversity of thought and stimulate research opportunities across the globe.

Unlike standard postdoctoral positions, the Challenge encourages applicants from anywhere around the world to devise their own research projects and help advance the next wave of therapeutics for people who need them most.

This follows the success of the inaugural 2022 programme in which six finalists were awarded fully funded research positions within the Company.

Submissions for the 2023 Challenge are open to final-year MD and/or PhD students and postdoctoral researchers until 30 June and successful candidates will compete to be awarded a fully funded postdoctoral research position and join the vibrant scientific community within AstraZeneca.

Working alongside a leading university, researchers will also receive access to in-house expertise, compounds, novel tools and technologies and mentoring support to develop their ideas and innovate.

Prof. Sir Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Our ambition through the R&D Postdoctoral Challenge is to promote a rich tapestry of ideas and create a diverse, global community of researchers with access to AstraZeneca’s cutting-edge facilities and world-leading expertise.

Last year, we were able to support all six of our finalists, and I am looking forward to seeing this year’s entries and helping even more early-career scientists translate their ideas into meaningful benefits for patients.”

Shortlisted applicants will have the chance to pitch their research ideas to a panel consisting of AstraZeneca leaders and external life science leaders in September, with the selection of finalists decided later in the year.

Proposals will be reviewed based on scientific merit, and their potential to create real impact for patients, society and healthcare systems.

Further information on the R&D Postdoctoral Challenge, including entry criteria and details on how to submit innovative research proposals, can be found at:

https://openinnovation.astrazeneca.com/rd-postdoctoral-challenge.html.

The R&D Postdoctoral Challenge forms part of AstraZeneca’s Early Talent programmes, nurturing the science leaders of tomorrow and encouraging diversity of thought within an environment that enables science to thrive. 

Notes

AstraZeneca’s global R&D footprint and productivity
In 2022 AstraZeneca invested $9.5 billion in R&D which represents 21% of Total Revenue, in order to continue to discover and develop medicines which transform the lives of patients.

The Company has three world class strategic R&D centres including The Discovery Centre (DISC) in Cambridge in the UK, one in Gaithersburg, Maryland in the greater Washington, D.C. region of the US, and another in Gothenburg in Sweden, as well as further hubs across the world.

It has integrated R&D teams and accelerated decision-making processes, using its unique scientific capabilities, to deliver one of the most productive pipelines in the industry.  

Since 2005, AstraZeneca has achieved an almost six-fold improvement in the proportion of its pipeline molecules that have advanced from preclinical investigation to completion of Phase III clinical trials – from 4% to 23%.

This improvement moves AstraZeneca well above the current industry average success rate of 14% in the 2018-2020 timeframe.

Of the Company’s 80,000 employees, more than 13,000 work exclusively in R&D.

In 2021, its scientists published a total of 871 manuscripts, with 196 in high impact peer-review journals (impact factor greater than or equal to 15 according to Reuters five-year rating), compared to one in 2010.”

https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-launches-call-for-entries-to-the-2023-global-rd-postdoctoral-challenge.html

Pfizer’s ZAVZPRET™ Migraine Nasal Spray Receives FDA Approval

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Pfizer’s ZAVZPRET™ Migraine Nasal Spray Receives FDA Approval

March 10, 2023: “Pfizer Inc. announced the U.S. FDA has approved ZAVZPRET™ (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults.

In its pivotal Phase 3 study, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at two hours post-dose.

The pivotal study also demonstrated pain relief as early as 15 minutes in a prespecified secondary endpoint versus placebo.

“The FDA approval of ZAVZPRET marks a significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer.

“ZAVZPRET underscores Pfizer’s commitment to delivering an additional treatment option to help people with migraine gain relief and get back to their daily lives. Pfizer will continue to build its migraine franchise to further support the billions of people worldwide impacted by this debilitating disease.”

The FDA approval is based on two pivotal randomized, double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profiles of ZAVZPRET for the acute treatment of migraine.

In these studies, ZAVZPRET was statistically superior to placebo on the co-primary endpoints of pain freedom (defined as a reduction of moderate or severe headache pain to no headache pain) and freedom from most bothersome symptom at two hours post-dose (defined as the absence of the self-identified most bothersome symptom).

The pivotal Phase 3 study published in The Lancet Neurology found ZAVZPRET showed broad efficacy by also demonstrating statistically significant superiority to placebo across 13 of 17 prespecified secondary outcome measures, including early time point endpoints (e.g., 15 and 30-minute pain relief and return to normal function at 30 minutes), return to normal function at 2 hours, and durable efficacy endpoints (e.g., 2-24 and 2-48 hour sustained pain freedom and sustained pain relief).

On the 14th endpoint, return to normal function at 15 minutes post-dose, the difference between ZAVZPRET and placebo was not significant. Consequently, in keeping with the trial’s statistical analysis plan, the remaining secondary endpoints were not formally tested.

“When a migraine hits, it has a significant negative impact on a person’s daily life,” said Kathleen Mullin, M.D., Associate Medical Director at New England Institute for Neurology & Headache.

“Among my migraine patients, one of the most important attributes of an acute treatment option is how quickly it works.

As a nasal spray with rapid drug absorption, ZAVZPRET offers an alternative treatment option for people who need pain relief or cannot take oral medications due to nausea or vomiting, so they can get back to normal function quickly.”

ZAVZPRET was well tolerated in clinical trials. The most common adverse reactions reported in at least 2% of patients treated with ZAVZPRET and at a frequency greater than placebo were taste disorders (includes dysgeusia and ageusia), nausea, nasal discomfort and vomiting.

ZAVZPRET is contraindicated in patients with a history of hypersensitivity to zavegepant or to any of its components.

Hypersensitivity reactions, including facial swelling and urticaria, have occurred with ZAVZPRET in clinical studies.

ZAVZPRET is anticipated to be available in pharmacies in July 2023.

About Migraine
Nearly 40 million people in the United States suffer from migraine and the World Health Organization classifies migraine as the second leading cause of disability in the world.

Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity often associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia).

About CGRP Receptor Antagonism
Small molecule CGRP receptor antagonists represent a novel class of drugs for the treatment of migraine.

For acute treatment, this unique mode of action offers an alternative to other agents, including those patients who have contraindications to the use of triptans or who have a poor response to triptans or are intolerant to them.

CGRP signal-blocking therapies have not been associated with medication overuse headache (MOH) or rebound headache, which can limit the clinical utility of other acute treatments.

About ZAVZPRET
Zavegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist and the only CGRP receptor antagonist in clinical development with both intranasal and oral formulations.

INDICATION

ZAVZPRET™ (zavegepant) is indicated for the acute treatment of migraine with or without aura in adults.

Limitations of Use: ZAVZPRET is not indicated for the preventive treatment of migraine.

IMPORTANT SAFETY INFORMATION

Contraindications: Hypersensitivity to ZAVZPRET or any of its components.

Warnings and Precautions: Hypersensitivity reactions, including facial swelling and urticaria, have occurred with ZAVZPRET. If a hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy.

Adverse Reactions: Most common adverse reactions (occurring in ≥2% of patients treated with ZAVZPRET and greater than placebo) for ZAVZPRET vs placebo were taste disorders including dysgeusia and ageusia (18% vs 4%), nausea (4% vs 1%), nasal discomfort (3% vs 1%), and vomiting (2% vs 1%).

Drug Interactions: Avoid use with drugs that inhibit or induce OATP1B3 or NTCP transporters. Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after ZAVZPRET administration.

Use in Specific Populations:Hepatic Impairment: Avoid use in patients with severe hepatic impairment. Renal impairment: Avoid use of ZAVZPRET in patients with creatine clearance (CLcr) less than 30 mL/min.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizers-zavzprettm-zavegepant-migraine-nasal-spray

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