October 01, 2021: “The U.S. FDA is announcing two upcoming meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss newly available data for the currently available COVID-19 vaccines.
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VRBPAC Meeting on Janssen and Moderna COVID-19 Vaccine Boosters
On Oct. 14 and 15, the advisory committee will meet to discuss the use of booster doses of the Moderna COVID-19 Vaccine and the Janssen COVID-19 Vaccine. Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older. The committee will also hear presentations and discuss the available data on the use of a booster of a different vaccine than the one used for the primary series of an authorized or approved COVID-19 vaccine (heterologous or “mix and match” booster).
“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic. It’s critical that as many eligible individuals as possible get vaccinated as soon as possible. Once vaccinated, we want to ensure that individuals continue to be protected against the adverse effects of COVID-19. The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
On Oct. 14, the committee will discuss an amendment to the emergency use authorization of the Moderna COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older.
On Oct. 15, the VRBPAC will discuss amending the emergency use authorization of Johnson and Johnson’s Janssen COVID-19 Vaccine for the administration of a booster dose, in individuals 18 years of age and older.
Additionally, on Oct. 15, the committee will hear a presentation from the National Institute of Health’s National Institute of Allergy and Infectious Diseases on the heterologous use of booster doses following the primary series of the three currently authorized or approved COVID-19 vaccines.
During the meeting, the committee will hear presentations from the companies on the data for their respective vaccines. The FDA will also present its own analyses of each of the manufacturers’ data. There will be an open public hearing each day during which the public will be given an opportunity to provide comments.
VRBPAC Meeting on Pfizer Data on Its COVID-19 Vaccine for Children 5-11
The FDA anticipates receiving a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. In anticipation of the request, the FDA is moving forward with scheduling an advisory committee meeting on Oct. 26 to inform the agency’s decision-making.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” said Acting FDA Commissioner Janet Woodcock, M.D.
The FDA intends to make background materials for both VRBPAC meetings available to the public, including the meeting agendas and committee rosters, no later than two business days before each meeting.”
October 01, 2021:”The U.S. FDA announced that, on behalf of the agency, the U.S. Marshals Service conducted a mass seizure of FDA-regulated spices and food additive products held for sale under insanitary conditions.
Specifically, these food products were exposed to widespread rodent infestation as well as other pests, such as live and dead insects.
The seizure was completed today at Lyden Spice Corporation in Miami, Florida.
The food products seized at the property include more than 25,000 boxes/bags of bulk ready-to-eat spices and food additives, such as monosodium glutamate, crushed red chili and sesame seeds.
“The FDA plays a critical role in safeguarding the U.S. food supply and helping to ensure that our food is not contaminated at any point during its journey along the supply chain,” said Acting FDA Commissioner Janet Woodcock, M.D. “We take our responsibility seriously and will continue to take action against those who threaten the safety and quality of the products we regulate as a necessary step to protect the public health and the safety of Americans.
The widespread insanitary conditions found at the Lyden Spice Corporation are disturbing and won’t be tolerated.”
The U.S. Department of Justice filed the complaint on behalf of the FDA in the U.S. District Court for the Southern District of Florida, alleging that the food products at Lyden Spice Corporation’s facility are adulterated under the Federal Food, Drug, and Cosmetic Act and requesting that the food products be condemned and forfeited to the United States.
The complaint alleges that an inspection of Lyden Spice Corporation that the FDA conducted between June 8 and June 28, 2021, revealed insanitary conditions, including rodent feces too numerous to count on and around pallets with containers of food, evidence of rodent gnawing and urine on food containers, and rodent nesting material between food pallets.
The FDA investigators also observed live and dead insects on food packaging, as well as apparent bird droppings in the food storage area.”
September 30, 2021:”Atezolizumab (also known as Tecentriq and made by Roche) has been recommended by NICE for people whose tumour expresses PD-L1 (a protein which prevents the body’s immune system killing the cancer cells) at a level of 5% of more and when platinum-containing chemotherapy is unsuitable.
The recommendation comes after additional clinical evidence which showed that people who have atezolizumab are likely to live up to 8 months longer than those who have platinum-containing chemotherapy was collected as part a Cancer Drugs Fund managed access agreement.
Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE said: “I am pleased we are able to recommend this life-extending treatment for people with this form of urothelial cancer.
The independent appraisal committee heard from the clinical and patient experts that there is an unmet clinical need for people with this form of cancer.
They also recognised that people value additional treatment options which have a positive impact not just in terms of extending their life, but in improving their quality of life too.
“Today’s decision comes after additional clinical evidence was collected as part of a managed access agreement through the Cancer Drugs Fund.
I am pleased we were able to not only secure access for people with this form of urothelial cancer in the interim but to now recommend it for routine use in the NHS.”
Urothelial carcinoma is cancer of some of the cells which form the inner lining of the bladder, urethra, ureter, or renal pelvis. Urothelial carcinoma is most common in the bladder, and accounts for 90% of bladder cancers.
There were 10,300 diagnoses of bladder cancer in 2013, accounting for 1 in every 30 new cases of cancer each year.”
September 30, 2021: “A study released from the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) estimated that more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021, with more than 8 in 10 of those youth using flavored e-cigarettes.
The report, published in the Morbidity and Mortality Weekly Report, was based on data from the 2021 National Youth Tobacco Survey (NYTS), a cross-sectional, self-administered survey of U.S. middle (grades 6–8) and high (grades 9–12) school students.
The study assessed current (used on one or more of the past 30 days) e-cigarette use; frequency of use; and use by device type, flavors and usual brand.
This NYTS—administered Jan. 18- May 21, 2021—was the first to be fully conducted during the COVID-19 pandemic. Data were collected using an online survey to allow eligible students to participate in the classroom, at home or in some other place to account for various school settings during this time.
Prior to the pandemic, the survey was conducted in person, inside the school classroom. Because of the changes in the way the survey was conducted this year, results of the 2021 NYTS cannot be compared to findings from previous surveys.
Nonetheless, the 2021 NYTS provides crucial information about youth use of e-cigarettes.
Notably, when many students were in remote learning environments that might have affected their access to tobacco products, an estimated 11.3% (1.72 million) of high school students and an estimated 2.8% (320,000) of middle school students reported current e-cigarette use.
“These data highlight the fact that flavored e-cigarettes are still extremely popular with kids. And we are equally disturbed by the quarter of high school students who use e-cigarettes and say they vape every single day,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.
“The FDA continues to take action against those who sell or target e-cigarettes and e-liquids to kids, as seen just this year by the denial of more than one million premarket applications for flavored electronic nicotine delivery system products.
It is critical that these products come off the market and out of the hands of our nation’s youth.”
Other Key Findings
Frequency of Use: Among youth who currently used e-cigarettes, 43.6% of high school students and 17.2% of middle school students reported using e-cigarettes on 20 or more of the past 30 days. Also among current users, more than 1 in 4 (27.6%) high school students and about 1 in 12 (8.3%) middle school students who used e-cigarettes used them daily.
Device Type Use: Among youth who currently used e-cigarettes, the most commonly used e-cigarette device type was disposables (53.7%), followed by prefilled or refillable pods or cartridges (28.7%), and tanks or mod systems (9.0%).
Flavor Use: Among youth who currently used e-cigarettes, 84.7% used flavored e-cigarettes including 85.8% of high school and 79.2% of middle school users. Overall, the most commonly used flavor types were fruit; candy, desserts, or other sweets; mint; and menthol (Note that these results refer to flavors other than tobacco).
Brand Use: Among high school students who currently used e-cigarettes, 26.1% reported their usual brand was Puff Bar, followed by Vuse (10.8%), SMOK (9.6%), JUUL (5.7%) and Suorin (2.3%). Among middle school students who currently used e-cigarettes, 30.3% reported their usual brand was Puff Bar, and 12.5% reported JUUL. Notably, 15.6% of high school users and 19.3% of middle school users reported not knowing the e-cigarette brand they usually used.
“This study shows that even during the COVID-19 pandemic, e-cigarette use among youth remains a serious public health concern,” said Karen Hacker, M.D., M.P.H., Director of CDC’s National Center for Chronic Disease Prevention and Health Promotion.
“It’s critical we continue working together to protect young people from the risks associated with tobacco product use, including e-cigarettes.
Our public health efforts include CDC’s National and State Tobacco Control Program, and resources for educators, parents and providers to warn youth about tobacco products and help them quit.”
Addressing Youth Tobacco Product Use
Youth use of tobacco products—in any form, including electronic nicotine delivery systems (ENDS) like e-cigarettes—is unsafe. Such products contain nicotine, which is highly addictive and can harm the developing adolescent brain. Using nicotine in adolescence may also increase risk for future addiction to other drugs.
Ongoing efforts to address youth e-cigarette use are critical, including the FDA’s significant progress made on the unprecedented number of timely premarket applications received by the Sept. 9, 2020, court-ordered deadline for deemed new tobacco products, including e-cigarettes.
The agency has taken action on over 96% of the applications to date, including issuing marketing denial orders (MDOs) for more than one million flavored ENDS products that are so popular with young people.
The MDOs were issued for products whose applications lacked sufficient evidence that such products have a benefit to adult smokers to overcome the public health concern posed by the well-documented and considerable appeal of the products to youth.
The FDA is aware of a number of companies, such as Puff Bar, claiming their products contain only synthetic nicotine not sourced from tobacco, which may raise separate regulatory and legal issues that the agency is considering how best to address.
Since 2014, e-cigarettes have been the most commonly used tobacco product among U.S. youth.
As the tobacco product landscape continues to evolve, the sustained implementation of comprehensive tobacco control and prevention strategies at the national, state, and local levels, coupled with FDA regulations, can prevent and reduce tobacco product initiation and use among youth.”
September 30, 2021: “The U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade.
“Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures; and monitoring the effectiveness of certain therapies,” said Laurel Burk, Ph.D., assistant director of the Diagnostic X-ray Systems Team in the FDA’s Center for Devices and Radiological Health.
“Today’s action represents the first major new technology for computed tomography imaging in nearly a decade and underscores the FDA’s efforts to encourage innovation in areas of scientific and diagnostic progress.”
The device uses the emerging CT technology of photon-counting detectors which can measure each individual X-ray that passes through a patient’s body, as opposed to current systems which use detectors that measure the total energy contained in many X-rays at once.
By ‘counting’ each individual X-ray photon, more detailed information about the patient can be obtained and used to create images with less information that is not useful in the review and analysis.
Computed tomography (sometimes called computerized tomography) is a noninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body.
Each cross-sectional image represents a ‘slice’ of the person being imaged, not unlike the slices in a loaf of bread. These cross-sectional images are used for a variety of diagnostic and therapeutic purposes.
CT scans can be performed on every region of the body for a variety of reasons. The CT system then converts these counts or measurements through complex software into the recorded images the health care provider reads and analyzes.
The new diagnostic imaging device, called Siemens NAEOTOM Alpha, is designed to transform the information from X-ray photons that pass through a patient’s body, and are received by a detector, into a detailed 3-dimensional image.
The images delivered by the system can be used by a trained physician as an aid in diagnosis or can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.
The FDA reviewed the Siemens NAEOTOM Alpha through the 510(k) premarket clearance pathway.
A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
The FDA granted clearance of Siemens NAEOTOM Alpha to Siemens Medical Solutions Inc.”
September 29, 2021: “The following quote is attributed to Thalia Mills, Ph.D., director, Division of Radiological Health, Office of In Vitro Diagnostics and Radiological Health, FDA’s Center for Devices and Radiological Health“The FDA is warning consumers that using the Safe-T-Lite UV WAND, a handheld ultraviolet-C (UV-C) germicidal wand intended for sanitization, may put you or a nearby person at risk of exposure to unsafe levels of UV-C radiation, and may cause injury to the skin, eyes or both after just a few seconds of exposure.
Some consumers may use the Max-Lux Safe-T-Lite UV WAND to disinfect surfaces in the home or similar spaces. This product emits unsafe levels of radiation and should not be used. The FDA advises that consumers who use the Safe-T-Lite UV WAND should consider using alternative disinfectant methods, such as general purpose disinfectants.
The agency will continue to monitor the issue and keep the public informed should significant new information become available.”
Additional Information
Today, the U.S. Food and Drug Administration issued a safety communication to warn consumers that the Safe-T-Lite UV WAND, a handheld ultraviolet-C (UV-C) germicidal product intended to disinfect surfaces in the home or similar spaces, may expose users or nearby persons to unsafe levels of UV-C radiation and may cause injury to the skin, eyes or both after a few seconds of exposure.
The Safe-T-Lite UV WAND is intended to be held in the hand of the user for 30 to 60 seconds, the duration of the sterilization process. This product emits a level of radiation more than 3,000 times faster than the international ultraviolet exposure limit External Link Disclaimer (at a distance of about 2 inches from the light source), and presents a risk of injury to the skin, eyes or both to the user and nearby persons within a few seconds of use.
If you have experienced an injury or a problem with a handheld UV-C germicidal product, it is important to report it to the manufacturer and the FDA. Additionally, manufacturers and anyone in the general public may use the Accidental Radiation Occurrence Report form to submit a report on any radiation incident or potentially hazardous event.”
September 29, 2021: “AstraZeneca’s Alexion has exercised its option to acquire all remaining equity in Caelum Biosciences for CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis.
AL amyloidosis is a rare disease in which misfolded amyloid proteins build up in organs throughout the body, including the heart and kidneys, causing significant organ damage and failure that may ultimately be fatal.
Approximately 20,000 people across the US, France, Germany, Italy, Spain and the UK live with AL amyloidosis classified as Mayo stage IIIa or IIIb disease.
CAEL-101 is currently being evaluated in the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme in combination with standard-of-care (SoC) therapy in AL amyloidosis.
Two parallel Phase III trials in patients with Mayo stage IIIa disease and in patients with Mayo stage IIIb disease respectively are ongoing.
Marc Dunoyer, Chief Executive Officer, Alexion, said: “With a median survival time of less than 18 months following diagnosis, there is an urgent need for new treatments for this devastating disease.
CAEL-101 has the potential to be the first therapy to target and remove amyloid deposits from organ tissues, improve organ function, and, ultimately, lead to longer lives for these patients.”
Financial considerations In 2019 Caelum and Alexion first entered into a collaboration whereby Alexion acquired a minority equity interest and an exclusive option to acquire the remaining equity in Caelum.
Alexion currently consolidates Caelum and reflects a non-controlling interest of $150m.
Upon closing the acquisition, which is expected to take place on 5 October 2021, Alexion will pay Caelum the agreed option exercise price of approximately $150m, with the potential for additional payments of up to $350m upon achievement of regulatory and commercial milestones.
AL amyloidosis AL amyloidosis is a rare disease caused by defective plasma cells in the bone marrow that produce abnormal antibody (immunoglobulin) proteins.
These abnormal proteins misfold and aggregate to form amyloids that may deposit in tissues and/or organs.
Amyloid accumulation in organs, particularly in the heart and kidneys, can cause widespread and progressive organ damage and high mortality rates, with death most frequently occurring as a result of cardiac failure
CAEL-101 CAEL-101 is a potentially first-in-class mAb designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis.
The antibody is designed to bind to misfolded light chain proteins and amyloid and shows binding to both kappa and lambda subtypes.
CAEL-101 has received Orphan Drug Designation from both the US Food and Drug Administration (FDA) and the European Commission as a potential therapy for patients with AL amyloidosis.
Additionally, the US FDA granted Fast Track Designation to CAEL-101 for AL amyloidosis in June 2021.
CARES Phase III clinical programme The CARES clinical programme consists of two parallel global Phase III trials which are evaluating the efficacy and safety of CAEL-101 in AL amyloidosis patients who are newly diagnosed and naïve to SoC treatment (based on a cyclophosphamide-bortezomib-dexamethasone regimen).
One trial is enrolling approximately 270 patients with Mayo stage IIIa disease and one trial is enrolling approximately 110 patients with Mayo stage IIIb disease. The primary endpoint for both clinical trials is overall survival and enrolment is underway.
In each study, participants are being randomised in a 2:1 ratio to receive either CAEL-101 plus SoC or placebo plus SoC once weekly for four weeks.
This will be followed by a maintenance dose administered every two weeks until the last patient enrolled completes at least 50 weeks of treatment.
Patients will continue follow-up visits every 12 weeks and will subsequently be enrolled in an open-label extension study.
Alexion Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc.
As a leader in rare diseases for nearly 30 years, Alexion is focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialisation of life-changing medicines.
Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on haematology, nephrology, neurology, metabolic disorders, cardiology and ophthalmology.
Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries.”
September 29, 2021: “Novartis, a leader in immuno-dermatology and rheumatology announced data from an international Phase IIIb study, which showed treatment with Cosentyx® (secukinumab) 300 mg in a 2 mL autoinjector (UnoReady® pen) resulted in high efficacy and convenient administration in adults with moderate to severe plaque psoriasis.
These data were presented at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress.
“Chronic diseases like psoriasis can often be difficult to manage and adherence to treatments can be a challenge for patients,” said Professor Bardur Sigurgeirsson, University of Iceland, lead author of the MATURE study.
“This study shows that a 300 mg dose of Cosentyx can be delivered in one injection, making it more convenient and simpler for patients to use, without compromising efficacy or safety.”
The MATURE study assessed the use of a Cosentyx 300 mg autoinjector, versus two 150 mg pre-filled syringes or placebo.
Patients using the 300 mg autoinjector reported significantly improved skin clearance measured by Psoriasis Area and Severity Index (PASI) 75 and 90 versus placebo.
“We’re always looking for ways to improve usability and adherence of all our therapies, so people get the most benefit and treatments are convenient to administer. With the Cosentyx 300 mg autoinjector, people with psoriasis can better manage their symptoms with fewer injections.
It’s great to know that all adults who trialed the Cosentyx UnoReady autoinjector said they were satisfied with how it worked,” said Todd Fox, Global Head of Medical Affairs for Immunology, Hepatology and Dermatology, Novartis.
The study showed high patient satisfaction, with 100% of those in the Cosentyx 300 mg UnoReady group reporting they were “very satisfied” or “satisfied” at Week 28. The safety profile reported was consistent with previous studies, and no new safety signals were observed.
The UnoReady pen was approved for use in Europe in November 2020 for all patients requiring a 300 mg dose of Cosentyx. Cosentyx is approved in over 100 countries at doses up to 300 mg for adults with moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis.
September 24, 2021: “The U.S. FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
In the short term, these new authorities essentially preserve status quo marketing conditions for these sunscreens.
However, the agency today proposed revisions and updates to those requirements related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements, and product labeling, among other provisions.
“Sun safety is important for everyone, regardless of your skin tone. Americans can reduce risks from sun exposure with continued use of sun protection measures including broad spectrum sunscreen with SPF values of at least 15,” said Acting FDA Commissioner Janet Woodcock, M.D.
“Today’s activities represent a key milestone in our implementation of transformative new authorities related to OTC drugs that will allow us to continue ensuring that sunscreens are safe and effective for frequent, life-long use and provide consumers with the protection they expect from these products.
We are committed to using our new authorities to help meaningfully advance innovative, safe and effective options for consumers and secure a robust OTC marketplace.”
The 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act reformed and modernized the way sunscreens marketed without approved applications are regulated in the U.S.
The Act establishes a deemed final order for sunscreens, which, along with other requirements established by the CARES Act, sets the current requirements for marketing these OTC sunscreen products.
The CARES Act did not change the scientific standards for determining whether a sunscreen may be legally marketed without an approved application.
OTC orders establish conditions under which the FDA permits certain OTC drugs to be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE), so long as they comply with all other applicable requirements.
The deemed final order for sunscreens includes certain requirements about active ingredients from the 1999 final monograph regulation for OTC sunscreen products, which never took effect.
It also includes labeling and effectiveness requirements from a final 2011 labeling and effectiveness testing rule.
The deemed final order essentially preserves the pre-CARES status quo marketing conditions for these sunscreens, as, before CARES was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy.
For this reason, the FDA believes that most sunscreens on the market are in compliance with the deemed final order. This order will remain in effect until the FDA issues another final order revising it.
The CARES Act required the FDA to issue a proposed revised order by Sept. 27, 2021.
The FDA is announcing the availability of the proposed order today that the Agency is using as a vehicle to efficiently transition its ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rulemaking process to this new order process.
The provisions in today’s proposed order are therefore substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens and are aimed at bringing sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective sunscreen products.
For example, the order proposes to update the GRASE status for the 16 active ingredients listed in the deemed final order.
It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements.
The order’s proposals related to SPF and broad spectrum are designed to ensure that consumers have access to sunscreens with adequate ultraviolet A rays (UVA) protection, given the growing body of data linking UVA exposure to skin cancers and other harms.
The order also proposes updates to how products are labeled to make it easier for consumers to identify key product information.
The agency will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order (and is considering all comments timely submitted to the 2019 proposed rule to be constructively submitted to the proposed order).
The CARES Act specifies that the effective date for the revised final order cannot be earlier than one year after its issuance.
Broad spectrum sunscreens with SPF values of at least 15 are only one element of a skin-cancer prevention strategy.
Other sun protective behaviors include: wearing protective clothing that adequately covers the arms, torso and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight.”
September 27, 2021: “AstraZeneca will present data across its COVID-19 and respiratory syncytial virus (RSV) pipeline at the 10th Annual IDWeek Virtual Conference, 29 September to 3 October 2021, illustrating its commitment to advancing innovative science in infectious diseases.
Data featuring AstraZeneca’s investigational long-acting antibody (LAAB) programmes – AZD7442 for COVID-19 and nirsevimab for RSV – as well as its COVID-19 vaccine Vaxzevria, will be presented as three late-breaking oral presentations.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The compelling data being presented at IDWeek reflect our scientific advances across infectious diseases in response to the COVID-19 pandemic and surges in respiratory syncytial virus cases.
Our PROVENT Phase III data demonstrate AZD7442 may offer much-needed protection for vulnerable populations who may not mount an adequate immune response to COVID-19 vaccination.”
Advancing COVID-19 prevention with cutting-edge science High-level efficacy and safety data from the PROVENT Phase III trial investigating AZD7442 for prevention of COVID-19 will be presented for the first time following the initial announcement in August.
The data showed that AZD7442 compared to placebo achieved a statistically significant reduction in the risk of developing symptomatic COVID-19 prior to virus exposure (pre-exposure prophylaxis).
More than 75% of participants in the trial had co-morbidities, which includes those with a reduced immune response to vaccination.
In PROVENT, the LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups.
A late-breaker oral presentation of Phase III results will show whether Vaxzevria prevents asymptomatic cases of COVID-19, as well as its capability to shorten viral shedding in breakthrough infections.
Understanding the duration of viral shedding may help the implementation of effective public health efforts to control the spread of the virus.
Late breaking data on nirsevimab The MELODY Phase III trial data for nirsevimab, an investigational long-acting antibody being developed by AstraZeneca and Sanofi, will demonstrate the potential of nirsevimab to help protect all infants entering their first RSV season with a single dose.
Key AstraZeneca presentations during IDWeek 2021
Lead author
Abstract title
Presentation details
COVID-19 (Long-acting antibody)
Levin, M
PROVENT: Phase 3 Study of Efficacy and Safety of AZD7442 (Tixagevimab/Cilgavimab) for Pre-exposure Prophylaxis of COVID-19 in Adults
Abstract #LB5Session: Late Breaker Abstracts: COVID-19 Treatment & Prophylaxis30 September 202117:15 – 18:30 ETPresentation time:18:15 – 18:30 ET
COVID-19 (Vaccine)
Sobieszczyk, M
Asymptomatic Infection and Duration of Viral Shedding in Symptomatic Breakthrough Infections in a Phase 3 Study of AZD1222 (ChAdOx1 nCoV-19)
Abstract #LB6Session: Late Breaker Abstracts: COVID-19 Vaccines, Epidemiology, and Clinical1 October 202110:00 – 11:15 ETPresentation time:10:00 – 10:15 ET
The Efficacy and Impact in Heathy Infants of Nirsevimab on Medically Attended RSV Lower Respiratory Tract Infection.
Abstract #LB13Session: Late Breaker Abstracts2 October 202113:15 – 15:00 ETPresentation time: 13:45 ET
AZD7442 AZD7442 is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) – derived from B-cells donated by convalescent patients after SARS-CoV-2 virus.
Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the human monoclonal antibodies bind to distinct sites on the SARS-CoV-2 spike protein and were optimised by AstraZeneca with half-life extension and reduced Fc receptor and complement C1q binding.
The half-life extension more than triples the durability of its action compared to conventional antibodies and could afford up to 12 months of protection from COVID-19 following a single administration.
The reduced Fc receptor binding aims to minimise the risk of antibody-dependent enhancement of disease – a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.
AZD7442 is being studied in a comprehensive clinical trial programme for both prevention and treatment of COVID-19.
In August, 2021, AstraZeneca announced positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial.
Other ongoing trials include TACKLE COVID-19, a Phase III mild-to-moderate COVID-19 outpatient treatment trial, and collaborator treatment trials in outpatient and hospitalised settings.
Preliminary ‘in vitro’ findings demonstrate that AZD7442 neutralises recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.12,13
AstraZeneca is preparing regulatory submission of the prophylaxis data to health authorities for potential emergency use authorisation or conditional approval of AZD7442.
Vaxzevria, formerly AZD1222 Vaxzevria was co-invented by the University of Oxford and its spin-out company, Vaccitech.
It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.
After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
The vaccine has been granted a conditional marketing authorisation or emergency use in more than 80 countries across six continents.
More than 1.1 billion doses of Vaxzevria have been supplied to more than 170 countries worldwide, including more than 100 countries through the COVAX Facility.
Nirsevimab Nirsevimab is an investigational long-acting antibody, being developed by AstraZeneca and Sanofi using AstraZeneca’s proprietary YTE technology, designed to protect all infants for the RSV season.
Due to its extended half-life technology, nirsevimab is being developed as a single dose for all infants experiencing their first RSV season and infants with congenital heart disease or chronic lung disease entering their first and second RSV season.
The current anti-RSV antibody, AstraZeneca’s Synagis, is limited to high-risk infants and provides one-month protection, requiring five injections to cover an RSV season.
Nirsevimab is designed to provide RSV protection to all infants via an antibody given directly to an infant to help prevent LRTI caused by RSV.
Unlike an active immunisation, monoclonal antibodies do not require the activation of the immune system to help offer rapid and direct protection against disease.
There has been a recent resurgence of RSV during the easing of COVID-19 public health measures.
Nirsevimab has been granted regulatory designations to facilitate expedited development by three major regulatory agencies around the world.
These include Breakthrough Therapy Designation by The China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation from the US Food and Drug Administration; and access granted to the European Medicines Agency PRIority MEdicines (PRIME) scheme.
Nirsevimab is currently under clinical investigation and has not been approved by any regulatory authority.
In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialise nirsevimab.
Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities and Sanofi will lead commercialisation activities and record revenues.
Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones.
The two companies share all costs and profits.
Revenue from the agreement is reported as Collaboration Revenue in the Company’s financial statements.
Related, in November 2018, AstraZeneca divested US commercial rights for Synagis to Swedish Orphan Biovitrum AB (publ) (Sobi) in addition to the right to participate in payments that may be received by AstraZeneca from the US profits or losses for nirsevimab.
Under the agreement, AstraZeneca received upfront consideration of $1.5bn, consisting of $1.0bn in cash and $500m in ordinary shares of Sobi upon completion, and will have received a total of $60m in non-contingent payments for nirsevimab during 2019-2021.
AstraZeneca will also receive up to $470m in sales-related payments for Synagis, a $175m milestone following the submission of the Biologics License Application (BLA) for nirsevimab and potential net payments of approximately $110m on achievement of other nirsevimab profit and development-related milestones.
Upon payment of the $175m milestone on BLA submission, Sobi’s ongoing participation will amount to AstraZeneca’s full share of profits or losses under the agreement with Sanofi for nirsevimab in the US.
AstraZeneca will continue to manufacture and supply nirsevimab globally and is entitled to an additional royalty from Sobi if profits from nirsevimab in the US exceed a pre-specified level.”
“September 25 was chosen as the date for World Pharmacists Day because the International Pharmaceutical Federation was founded on this day in 1912; thus, it was only natural that the Turkish members of the council proposed in 2009 that September 25 be observed as World Pharmacists Day.
On September 25, the world celebrates Pharmacist Day. Pharmacists celebrate World Pharmacists Day to demonstrate their commitment to organising activities that promote and advocate for the pharmacist’s role in improving health in all parts of the world.
Table of Contents
Pharmacist Day Themes
World Pharmacist Day 2021 – Pharmacy: Always Trusted For Your Health
World Pharmacist Day 2020 – Transforming global health
World Pharmacist Day 2019 – Safe and effective medicines for all
World Pharmacist Day 2018 – Pharmacists: Your medicines experts
World Pharmacist Day 2017 – From research to health care: Your pharmacist is at your service
World Pharmacist Day 2016 – Pharmacists: Caring for you
World Pharmacist Day 2015 – Pharmacists: Your partners in health
World Pharmacist Day 2014 – Access to pharmacists is access to health
World Pharmacist Day 2013 – Pharmacists: simplifying your medicines use, no matter how complex
World Pharmacist Day 2012 – Pharmacists – Your partners in using medicines responsibility
Pharmacist Day will serve as a forum for interaction among pharmacists from various sectors and backgrounds, as well as professional input in the field of pharmacy.
Suggestions for Pharmacist Day, the following are some of the activities that can be done: –
1. For your patients: Screening and testing for some common disorders in patients, as well as reviewing their medications and providing necessary medication safety counselling.
2. To your pharmacist: The most loving gift you can give your pharmacist is a heartfelt “thank you.” You could also give him/her a pharmacist-themed gift to make him/her happy.
3. To your fellow pharmacist: If you are a pharmacist or a pharmacy manager, you should host an event to honour your fellow pharmacists who work hard and make significant contributions to society.
You can host a luncheon, tea, or other event and thank them with gifts such as gift certificates, name tag holders, mugs, and so on.
4. Set up an education and cross-training programme for them where they can share their pharmacy experiences.
Give the pharmacists a certificate of appreciation from the pharmacy organisation or institution.
5. If you are a student, fellow health professionnal : Take a picture of all of the pharmacists on staff, post it to the bulletin board, and write them an encouraging remark.
On September 25, 2013, the Pharmacy Council of India will commemorate ‘Pharmacist Day.’ You are also encouraged to commemorate “Pharmacists Day” on September 25th each year by organising the above activities, which will help to promote the morale of registered pharmacists and student pharmacists, as well as raise public awareness of the pharmacy profession.”
September 24, 2021: “Positive high-level results from the PROpel Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) versus standard-of-care abiraterone as a 1st-line treatment for men with metastatic castration-resistant prostate cancer (mCRPC) with or without homologous recombination repair (HRR) gene mutations.
At a planned interim analysis, the Independent Data Monitoring Committee (IDMC) concluded that the trial met the primary endpoint of rPFS in men with mCRPC who had not received treatment in the 1st-line setting including with new hormonal agents (NHAs) or chemotherapy.
The trial also showed a trend at this interim analysis towards improved overall survival (OS). However, the data are still immature and the trial will continue to assess OS as a key secondary endpoint.
The safety and tolerability were consistent with the known profiles of each medicine.
Prostate cancer is the second-most common cancer in men and despite an increase in the number of available treatments for men with mCRPC, five-year survival remains low.1
Susan Galbraith, Executive Vice President, Oncology R&D, said: “Today, men with metastatic castration-resistant prostate cancer have limited options in the 1st-line setting, and sadly often the disease progresses after initial treatment with current standards of care.
These exciting results demonstrate the potential for Lynparza with abiraterone to become a new 1st-line option for patients regardless of their biomarker status and reach a broad population of patients living with this aggressive disease. We look forward to discussing the results with global health authorities as soon as possible.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “We are encouraged by the PROpel results and the clinical benefit Lynparza in combination with abiraterone demonstrated versus abiraterone alone as a 1st-line treatment option for men with metastatic castration-resistant prostate cancer.
Today’s results build on MSD and AstraZeneca’s commitment to bring Lynparza earlier in lines of treatmentand to more patients with advanced prostate cancer.”
The data will be presented at an upcoming medical meeting.
Metastatic castration-resistant prostate cancer Metastatic prostate cancer is associated with a significant mortality rate. Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.
In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.3 Approximately 10-20% of men with advanced prostate cancer will develop CRPC within five years, and at least 84% of these men will have metastases at the time of CRPC diagnosis.
Of men with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.
Despite advances in treatment for men with mCRPC, five-year survival is low and extending survival remains a key treatment goal.
PROpel PROpel is a randomised, double-blind, multi-centre Phase III trial testing the efficacy, safety, and tolerability of Lynparza versus placebo when given in addition to abiraterone in men with mCRPC who had not received prior chemotherapy or NHAs in the 1st-line setting.
Men in both treatment groups will also receive either prednisone or prednisolone twice daily. The primary endpoint is rPFS and secondary endpoints include OS and time to first subsequent anticancer therapy or death.
The trial enrolled men with or without HRR gene mutations.
They may have previously been treated with docetaxel at a prior stage of disease. The trial excluded men with prior treatment with abiraterone. Treatment with any other NHA must have been stopped one year or longer prior to randomisation.
Men must have had a performance status of 0-1 as defined by the Eastern Cooperative Oncology Group (ECOG) criteria and be a candidate for abiraterone treatment with documented evidence of progressive disease.
Preclinical trials in prostate cancer report a combined anti-tumour effect when PARP inhibitors and NHAs are administered together.
PARP-1 is involved in the co-regulation of the androgen-receptor (AR) pathway, potentially leading to cooperation between PARP inhibitors and NHAs in blocking AR signalling.
PARP inhibition plus androgen deprivation could significantly reduce the growth of prostate cancer cells independent of HRR gene status. Other trials revealed that treatment with NHAs inhibit the transcription of some HRR genes, therefore, inducing HRR deficiency and increased sensitivity to PARP inhibitors via non-genetic mechanisms.
