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Novartis announces FDA and EMA filing acceptance of ofatumumab (OMB157), a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

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Novartis announces FDA and EMA filing acceptance of ofatumumab (OMB157), a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

Feb 24, 2020: Novartis announced that both the USFDA and EMA have accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in the adults.

Ofatumumab is a novel B-cell therapy that delivers sustained efficiency with a favorable safety profile.

If approved, ofatumumab has the prospective to become a first-choice treatment for the broad RMS population and the first B-cell therapy that can be easy to start and manage in a monthly subcutaneous injection that can be self-administered at home using an autoinjector pen.

The regulatory applications are based on the positive data from Phase III ASCLEPIOS I and II studies, which investigated the effectiveness and safety of monthly subcutaneous ofatumumab 20mg against once daily oral Aubagio®* (teriflunomide) 14mg in adults with RMS. In both head-to-head studies, ofatumumab demonstrated dominance over Aubagio® in patients with RMS

All research reached the primary endpoints where ofatumumab demonstrated a highly significant and clinically meaningful decrease in the number of reported relapses, measured as the annualized relapse rate (ARR). Key secondary delay time endpoints for confirmed progression of disability (CDP) were also met. Data presented at the 35th Congress of the European Committee for Multiple Sclerosis Treatment and Research (ECTRIMS) showed that ofatumumab reduced ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25) (p<0.001 in both studies) respectively in ASCLEPIOS I and II compared with Aubagio ®. Showed highly important suppression of both Gd+ T1 lesions and new or enlarging T2 lesions, demonstrating a profound abrogation of new inflammatory activity. Showed a relative risk reduction of 34.4%  in three-month CDP and 32.5%  in six-month CDP in pre-specified pooled analyses

In general ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favorable safety profile. The safety profile of the ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results.

Additionally, Novartis has completed the APLIOS study, an open-label Phase II study which is to determine the bioequivalence of subcutaneous administration of ofatumumab via a pre-filled syringe – as used in ASCLEPIOS I and II – and an autoinjector pen in patients with RMS. The positive results of the study will be presented at the Americas Committee for Treatment and Research in the Multiple Sclerosis (ACTRIMS) Forum in Florida, US. These results show that ofatumumab offers a highly efficient B-cell therapy that can be self-administered at home using a patient-friendly autoinjector pen.

Regulatory approval for the ofatumumab in US is expected in June 2020 and in Europe by Q2 2021. Novartis is committed to bringing ofatumumab to the patients worldwide and additional regulatory filings are currently underway.
https://www.novartis.com/news/media-releases/novartis-announces-fda-and-ema-filing-acceptance-ofatumumab-novel-b-cell-therapy-patients-relapsing-forms-multiple-sclerosis-rms

Novartis receives EC Approval for Beovu®(brolucizumab), a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

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Novartis receives EC Approval for Beovu®(brolucizumab), a next-generation anti-VEGF treatment for wet AMD, a leading cause of blindness worldwide

Feb 17, 2020: Novartis announced the European Commission has approved Beovu® (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD). Beovu is the first EC-approved anti-VEGF treatment to demonstrate superior resolution of the retinal fluid (IRF/SRF), a key marker of the disease activity, versus aflibercept (secondary endpoints).

“Beovu also offers the ability to start qualified wet AMD patients on a three-month dosing interval immediately after the loading phase. This decision of EC is applicable to all 27 European Union member states as well as the UK, Iceland, Norway and Liechtenstein.

 “Drying the retina is one of the main goals in the treatment of wet AMD with anti-VEGF therapy.”Wet AMD is a chronic, degenerative eye disease caused by excess VEGF, a protein that encourages the development of enlarged blood vessels below the macula, the region of
the retina responsible for sharp, central vision. The condition is a leading cause of significant
loss of vision and blindness in individuals over 65 years of age, affecting more than 20 million people worldwide. Initial symptoms of wet AMD include blurry or wavy vision. As the disease progresses, patients lose central vision, making it complicated to see objects directly in front of them.

The EC approval was based on the findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu met the primary endpoint, demonstrating gains in the best-corrected visual acuity (BCVA) that were non-inferior to aflibercept at year one (week 48). Vision gains at year one and was maintained at year two.

In HAWK and HARRIER, over half of the patients were maintained on the three-month dosing interval (56% in HAWK and 51% in HARRIER) at year one. The leftover patients in the study were treated on a two-month dosing interval.

Novartis received approval from the U.S. FDA in October 2019 for Beovu for the treatment of wet AMD. Beovu received Swissmedic approval in Switzerland and Australian TGA approval in January 2020  for the treatment of wet AMD. Novartis is committed to bringing Beovu to the patients worldwide, and other regulatory filings are at present underway in Canada, Japan and Brazil.

About Beovu (brolucizumab): Beovu (brolucizumab, also known as RTH258) is the most
scientifically advanced single chain humanized fragment of an antibody (scFv). Due to their small size, improved tissue penetration, rapid clearance from systemic circulation and drug delivery characteristics, singlechain antibody fragments are highly sought after in drug development.

About wet age-related macular degeneration
Wet AMD is the leading cause of severe vision loss and legal blindness in the people above 65 years age in North America, Europe, Australia and Asia, impacting an approximate 20 million people worldwide. Wet AMD occurs when abnormal blood vessels from the bottom of the macula, the area of the retina responsible for the sharp, central vision. These blood vessels are fragile and leak fluid, disrupting the typical retinal architecture and eventually causing damage to the macula”.

https://www.novartis.com/news/media-releases/novartis-receives-ec-approval-beovu-next-generation-anti-vegf-treatment-wet-amd-leading-cause-blindness-worldwide

US FDA Grants Orphan Drug Designation for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

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US FDA Grants Orphan Drug Designation for Retrotope’s RT001 in the Treatment of Progressive SupraNuclear Palsy (PSP)

Feb. 18, 2020: Retrotope announced that the U.S.FDA Office of Orphan Products Development granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug (RT001) for the treatment of Progressive SupraNuclear Palsy (PSP).

Physicians collaborating with the Retrotope have earlier received approval from the FDA’s Division of Neurology Products to test RT001 in Expanded Access trials of three patients having PSP, an orphan neurodegenerative disorder that causes progressive impairment of the balance and walking; impaired eye movement, abnormal muscle rigidity; dysarthria; and dysphagia and eventual death.

PSP is a serious neurodegenerative disease that intensely affects the quality and length of life in adults. Patients are usually disabled within 3-5 years of disease onset. It affects an approximate 17,500 adults in the US. The exact cause of PSP is not known, but it is a form of tauopathy, in which abnormal phosphorylation and accumulation of the protein tau in mid brain leads to destruction of the vital protein filaments in nerve cells, causing their death. Most cases appear to be irregular as an acquired tauopathy and there is no approved drug therapy. A regionally specific increase in the lipid peroxidation has been observed in PSP and mitochondrial structures and functions are compromised and leads to profound oxidation damage. 

RT001 is a chemically stabilized fatty acid that, via a novel mechanism, confers resistance to lipid peroxidation in mitochondrial and cellular membranes. In PSP patient mesenchymal stem cells, RT001 has been shown to decrease lipid peroxidation levels and restore mitochondrial structure and function to damaged cells. As RT001 is distributed across human tissues as an essential fat, it is expected to decrease the amount of lipid peroxidation, restore normal mitochondrial function and prevent mitochondrial cell death.https://fda.einnews.com/pr_news/510001029/us-fda-grants-orphan-drug-designation-for-retrotope-s-rt001-in-the-treatment-of-progressive-supranuclear-palsy-psp

MediciNova Receives Notice of Allowance from the Japan Patent Office for New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH in Japan

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MediciNova Receives Notice of Allowance from the Japan Patent Office for New Patent Covering MN-001 and MN-002 for the Treatment of Advanced NASH in Japan

Feb. 17, 2020: MediciNova announced that it has received a Notice of Allowance from the Japan Patent Office for a pending patent application which covers MN-001 (tipelukast) and MN-002 (a chief metabolite of MN-001) for the treatment of advanced non-alcoholic steatohepatitis (NASH). 

The patent maturing from this approved patent application is scheduled to expire no earlier than May 2035 upon issuance. The permissible statements cover MN-001 and MN-002 for use in treating an advanced NASH patient.

Advanced patients with hepatic fibrosis, spider angiomata, ascites, splenomegaly, hard liver border, palmar erythema, asterixis, portal hypertension, hepatic scarring, cirrhosis, or hepatocellular carcinoma (HCC) are also covered by the permitted claims. Furthermore, the permissible claims cover MN001 and MN 002 for use in hepatic fibrosis reduction and for use in patients with reduced hepatic scarring. The allowed claims include oral administration, including tablets and capsules, as well as liquid dosage forms. MN 001 (tipelukast) is a novel, orally bioavailable small molecule compound thought to exert its effects in preclinical models through several mechanisms to achieve its anti-inflammatory and anti fibrotic action, including leukotriene (LT) receptor antagonism, phosphodiesterase inhibition (PDE) (mainly 3 and 4) and 5-lipoxygenase inhibition (5-LO).

 The 5 LO / LT pathway was postulated as a pathogenic factor in the development of fibrosis, and the inhibitory effect of MN 001 on 5 LO and the 5 LO / LT pathway is considered a novel approach to fibrosis treatment. MN-001 has been shown to down-regulate the fibrosis-promoting gene expression including LOXL2, Collagen Type 1 and TIMP-1.
https://investors.medicinova.com/news-releases/news-release-details/medicinova-receives-notice-allowance-new-patent-covering-mn-17

Arctoris announces a formal partnership with Molecule to tackle the innovation crisis in the drug discovery and development

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Arctoris announces a formal partnership with Molecule to tackle the innovation crisis in the drug discovery and development

Feb 10, 2020: Arctoris Ltd has announced a formal partnership with Molecule to address the ongoing crisis of innovation faced by drug discovery and development across industry and  academia alike. “Arctoris helps researchers and biotechnology entrepreneurs to design and conduct advanced cellbased, molecular biology, and biochemical assays remotely through its fully automated drug discovery platform. Together with Molecule’s collaborative IP ownership network, which enables drug development stakeholders to collaborate and share ownership of the IP they work to develop, Arctoris and Molecule are positioned to take crucial steps to make drug discovery and production quicker, cheaper, less risk-prone and more competitive at all levels.

“Drug discovery researchers worldwide face enormous challenges posed by a wide-ranging lack of reproducibility and the limited ease of use of standardised, structured, high-quality data. By partnering with Molecule, we plan to make drug discovery and development more democratic, collaborative, and well-organized in the interest of bringing higher-quality therapeutics to the patients faster through the combination of robotics, AI and a distributed research platform,” said Martin-Immanuel Bittner, MD DPhil, Co-Founder and CEO of Arctoris.
Arctoris has planned and built a fully automated research facility based in Oxford (UK), where robotics perform a range of the most recurrent drug discovery assays for the researchers globally. The company offers the complete system in order to generate, analyse and visualize research data in a secure cloud environment, leveraging the benefits of the robotic experimentation, and providing full transparency, precision, and consistency in the preclinical R&D. Using the Arctoris platform, researchers worldwide can enjoy accelerated progress in their research, making discoveries faster, cheaper and more economically, while being liberated from manual work.
Jointly, Arctoris and Molecule will combine their technologies to create a modular pipeline for the distributed therapeutics development in the durability space and adjacent fields – a pipeline in which they will engage universities, patient advocacy groups, pharmaceutical and biotechnological companies, as well as investors”.
https://www.pharmiweb.com/press-release/2020-02-17/arctoris-announces-partnership-with-molecule-to-tackle-the-innovation-crisis-in-drug-discovery-and-development

Lupin received approval from U.S. FDA and launches Moxifloxacin Ophthalmic Solution USP 0.5%

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Lupin received approval from U.S. FDA and launches Moxifloxacin Ophthalmic Solution USP 0.5%

Feb 14, 2020: Pharma major Lupin Limited announced the launch of Moxifloxacin Ophthalmic Solution USP, 0.5%, having received an approval from the U.S. FDA earlier. The product would be manufactured at the Lupin’s Pithampur (Unit-II) facility in India. Moxifloxacin Ophthalmic Solution USP, 0.5% is the AT2-rated generic equivalent of the Moxeza® of Novartis.

It is indicated for the treatment of bacterial conjunctivitis which is caused by susceptible strains of certain organisms. Moxifloxacin Ophthalmic Solution USP, 0.5% (RLD: Moxeza®) had an annual sales of about USD 10 million in the U.S. (IQVIA MAT December 2019).

Lupin has 15 production facilities, seven research centres, more than 20,000 global employees, and has been widely known as a ‘ great place to work ‘ in the biotechnology & pharmaceuticals industry.
http://www.lupinpharmaceuticals.com/lupin-launches-moxifloxacin-ophthalmic-solution-usp-0-5.htm

FDA grant approval for GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States

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FDA grant approval for GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States

Feb 17, 2020: GlaxoSmithKline announced that the U.S.FDA has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the wrist, elbow, hand, foot, ankle or knee in adults (18 years and older).  

After the FDA’s approval, Voltaren Arthritis Pain becomes the first and the only prescription-strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain accessible OTC in the United States.

“Voltaren Gel, to whom GSKCH has the rights, is currently available in the US only with a prescription. Voltaren Arthritis Pain’s OTC approval today will provide over – the counter access to this topical treatment option for the nearly 30 million Americans with osteoarthritis. 

Franck Riot, Head of R&D, GSK Consumer Healthcare said: “For the millions of the people around the world living with arthritis, joint pain and stiffness are everyday realities. At GSK, we are committed to getting better the quality of life of these people and today’s approval is progress towards this, providing consumers in the US with increased right to use an effective, proven arthritis pain relief option.

At present Voltaren is the number 1- OTC topical pain relief brand globally, and we look forward to expanding its accessibility in the US.”

Additionally, the Osteoarthritis Research Society International (OARSI)  just updated and expanded their new guidelines for non-surgical management of OA by developing patient-focused treatment recommendations. These updated guidelines powerfully recommend topical non-steroidal anti-inflammatory drugs (NSAIDs) for persons with knee OA.  Of the non-core interventions measured as part of this guideline update, topical NSAIDs were suggested more strongly than all oral analgesics due to favourable balance of consistent effectiveness and minor transient side effects. The submission in support of the Voltaren Arthritis Pain approval today was based on clinical evidence in hand and knee OA supporting the initial drug approval. The data showed a clear and appreciable progression of pain relief starting as early as week 1 (as demonstrated by significant pain symptom changes across multiple pre-specified endpoints).

About Voltaren Arthritis Pain: The active ingredient in Voltaren Arthritis Pain, diclofenac sodium, is an effective medicine that is clinically proven in order to relieve joint pain due to arthritis. Voltaren Arthritis Pain penetrates through the skin at the application site in order to deliver arthritis pain relief. Voltaren Arthritis Pain offers patient who suffers from OA a different option to oral analgesics.  It targets pain directly at the site and amount of the diclofenac sodium that is systemically absorbed from the Voltaren Arthritis Pain is on average 6% of the systemic exposure from an oral form of the diclofenac sodium. GSK anticipates Voltaren Arthritis Pain will be accessible on US shelves in Spring 2020”. For more information, visit www.VoltarenGel.com.
https://us.gsk.com/en-us/media/press-releases/fda-approves-gsk-s-voltaren-arthritis-pain-for-over-the-counter-use-in-the-united-states/

Health ministry issues notification to regulate all the medical devices under D&C Act from April 1, 2020

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Health ministry issues notification to regulate all the medical devices under D&C Act from April 1, 2020

Feb 11, 2020: Union health ministry has notified that all the medical devices will nowadays regulated under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for efficient compliance.

“The ministry after consultation with the Drugs Technical Advisory Board (DTAB) has further notified to amend the Medical Devices Rules, 2017 and precised that these rules may be called the Medical Devices (Amendment) Rules, 2020 and will come into force on April 1, 2020.


According to a Gazette Notification dated February 11, 2020, after consultation with the DTAB, the health ministry hereby specifies that all the medical devices that are intended for use in human beings or animals will be regulated as drugs with effect from the April 1, 2020, which includes all the devices including an instrument, apparatus, implant, appliance, material or other article, whether used alone or in combination, also including a software or an accessory, intended by its producer to be used particularly for the human beings or animals which does not attain the primary intended action in or on human body or animals by any the pharmacological or immunological or metabolic means, but which may help in its intended function by such means for one or more of the specific purposes of ?(i) diagnosis, prevention, monitoring, treatment or alleviation of any the disease or disorder; (ii) diagnosis, monitoring, treatment, alleviation and assistance for, any injury or disability; (iii) investigation, replacement or modification or support of anatomy or of a physiological process; (iv) supporting or satisfying life; (v) disinfection of the medical devices; and (vi) control of the conception.”
The notification further states that “In the Medical Devices Rules, 2017 (here in after to be referred as said Rules), after Chapter III, the following Chapter IIIA will be inserted, namely-“Chapter IIIA Registration of certain Medical Devices 19a. This Chapter shall be applicable to all devices notified under clause (b) of section 3 of the Act except the medical devices and devices specified in the Eighth Schedule of these rules. The Medical devices referred to in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO) for this purpose.

The notification also states that any person who imports any medical device referred in rule 19A shall upload the following information relating to that medical device for registration on the “Online System for Medical Devices” established by the CDSCO for this purpose. The importer shall upload the name of the company or firm or any other entity importing the medical device and specification and standards of that medical device and also details of the medical device. Welcoming the move, Pavan Choudary, chairman and director-general, Medical Technology Association of India (MTaI) said, “We welcome the government’s decision to regulate all devices. These regulations, that are a continuation of the Medical Devices Rules 2017, which were launched after meticulous deliberations for 2 years, are in line with the government’s vision to provide equitable access to quality healthcare. It is also noteworthy that health ministry is recruiting competent resources to cater to the additional workload that these new regulations will bring.”

file:///E:/website%20matter/Gsr102eRegistration%20of%20certain%20medical%20devices.pdf

New Phase IIIb Interim Data from the STARDUST Study Shows about Two-Thirds of Patients with Moderately to Severely Active Crohn’s Disease Achieved Clinical Remission After Two Doses of the STELARA® (ustekinumab)

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New Phase IIIb Interim Data from the STARDUST Study Shows about Two-Thirds of Patients with Moderately to Severely Active Crohn’s Disease Achieved Clinical Remission After Two Doses of the STELARA® (ustekinumab)

Feb. 14, 2020: The Janssen Pharmaceutical Companies of Johnson & Johnson announced temporary data from the Phase IIIb STARDUST study. At week 16, 79 per cent of the patients with moderately to severely active Crohn’s disease (CD) achieved clinical response1 and 67 per cent were in clinical cutback after receiving one ~6 mg/kg IV dose followed by one 90 mg SC dose of the STELARA® (ustekinumab), open-label.

Intestinal ultrasound (IUS) responses were considered and were detected as early as week 4. Week 16 data (digital oral presentation, or DOP 13) and IUS response data (DOP 10) from STARDUST, also presented as digital oral presentations at the 15th Congress of the European Crohn’s & Colitis Organization (ECCO).

The primary endpoint of the 48-week STARDUST study is relative endoscopic response among all adult patients with CD receiving STELARA maintenance therapy.

At week 16, patients who attained ≥70 point decrease in Crohn’s Disease Activity Index score (CDAI70 responders) were randomized into the treat-to-target or routine standard of care treatment groups at the 1:1 ratio.

“Of the 220 CDAI70 responders randomized to treat-to-target arm, 37 percent attained endoscopic response at the week 16.

Endoscopy at week 16 was measured only in the treat-to-target group. Treat-to-target is the practical treatment strategy where regularly monitored outcomes, like endoscopic response, biomarkers and clinical symptoms, guide use of the medication. 

STARDUST is the first study of a treat-to-target strategy in the CD using endoscopic response to guide treatment.

IUS is a corresponding method of assessing CD activity which is based upon measuring transmural bowel features, like the thickness of the bowel wall and presence of the hypervascularization. STARDUST is the first study in order to use IUS for monitoring CD patients in an interventional setting. Prospect studies need to verify whether early IUS response at week 4 is predictive of longer-term (i.e., week 16 and up to week 48) clinical and endoscopic outcomes for the CD patients. Janssen is presenting a total of the 23 abstracts at this year in ECCO congress. At present STELARA is approved for the treatment of adults with moderately to severely active Crohn’s disease in the U.S., Canada, EU and Japan.

About STARDUST Trial
STARDUST is a randomized, international, multicenter, interventional Phase IIIb study assessing the proportion of patients with endoscopic response, identified as a 50% reduction in simple endoscopic score of Crohn’s disease (SES-CD) at week 48 from baseline. STARDUST is evaluating 500 participants receiving an IV induction dose of STELARA 6 mg/kg, followed by a week 8 injection of STELARA 90 mg SC. At week 16, patients with a 70 point CDAI reduction (CDAI70) were randomized to dose-to target or standard arms (1:1 ratio) and followed through the end of the study (48 weeks).

About STELARA® (ustekinumab)
STELARA® (ustekinumab), a human IL-12 and IL-23 antagonist, is accepted in the United States for the treatment of:
 1) Adults and children (12 years) and older with moderate to severe plaque psoriasis and are candidates for the phototherapy or systemic therapy;
2) Adult patients (18 years or older) who have active psoriatic arthritis, used alone or in combination with the methotrexate (MTX);
3) Adult patients (18 years and older) with moderately to harshly active Crohn’s disease;
4) Adult patients (18 years and older) with moderately to harshly active ulcerative colitis.

STELARA Dosing for Crohn’s Disease
Adults with Crohn’s disease will receive the first dose of STELARA through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. It takes at least 1 hour to receive the full dose of medicine. STELARA will then be given as an injection under the skin (subcutaneous injection) 8 weeks after the first dose of STELARA, then every 8 weeks thereafter. See full Prescribing Information for Dosing Information for other indications. The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.

IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medicine that can affect your immune system. STELARA® have serious side effects including:

Serious Infections
It lowers the ability to fight infections and may increase the risk of infections. While taking STELARA®, patients may suffer from serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

Before starting STELARA®, tell your doctor if you:
think you have any type of infection or have symptoms of an infection such as:
fever, sweats, or chills
muscle aches
cough
feel very tired
weight loss
shortness of breath
blood in phlegm
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
burning when you urinate or urinate more often than normal are being treated for an infection.
get a lot of infections or have infections that keep coming back.

 “After starting STELARA®, call your doctor right away if you have any symptoms of an infection (see above). People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and the interleukin 23 (IL‐23) are at a higher risk for the certain serious infections that can spread throughout the body and cause death. People who take STELARA® may also get these infections”.

Cancers
STELARA® can decrease the activity of your immune system and add to your risk for certain types of cancer. Tell your doctor if you ever had any type of cancer. Some people who had risk factors for skin cancer can develop certain types of skin cancers while receiving STELARA®. Tell your doctor if you observe any new skin growths.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS is a rare condition that can affect the brain and can cause death. If RPLS can detect early and treated, most people can recover.

Serious Allergic Reactions: If you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash then stop using STELARA® and get medical help right away

Lung Inflammation: Cases of lung inflammation can occur in some people who receive STELARA® and may be serious. You should not receive the BCG vaccine during one year before receiving the STELARA® or one year after you stop receiving STELARA®. Tell your doctor about all the medicines you take, including prescription and all other medicines, vitamins, and herbal supplements.

When prescribed STELARA®: Use STELARA® exactly as your doctor prescribed you.STELARA® is intended for the use under the guidance and supervision of your doctor. In children 12 years and older, it is suggested that STELARA® can be administered by a healthcare provider. Common side effects of STELARA® include: nasal congestion, and runny nose, sore throat, upper respiratory infections, fever, headache, tiredness, nausea, itching and vomiting, redness at the injection site, urinary tract infections, vaginal yeast infections, sinus infection, stomach pain, diarrhoea, and joint pain. These are not all of the possible side effects with STELARA®. Discuss with your doctor about any side effect that you experience.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088”.
https://www.janssen.com/new-phase-3b-interim-data-stardust-study-show-two-thirds-patients-moderately-severely-active-crohns

Deciphera Pharmaceuticals Announces U.S. FDA Acceptance of NDA and Priority Review for Ripretinib in the Patients with Advanced Gastrointestinal Stromal Tumors

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Deciphera Pharmaceuticals Announces U.S. FDA Acceptance of NDA and Priority Review for Ripretinib in the Patients with Advanced Gastrointestinal Stromal Tumors

Feb. 12, 2020: Deciphera Pharmaceuticals announced that the U.S. FDA has accepted for Priority Review its NDA seeking approval for ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST).

The FDA granted Priority Review for the NDA, which provides for a six-month review, and allocated a Prescription Drug User Fee Act (PDUFA) target action date of Aug. 13, 2020.

“The FDA’s acceptance of our NDA conveys us one step nearer to our goal of providing patients with the advanced GIST a potential new treatment option.”

Priority Review designation is for drugs that, if approved, would be considerable improvements in the safety or efficiency of the treatment, diagnosis, or prevention of the serious conditions when compared to the standard applications.

Under the PDUFA, a Priority Review targets a review time of six months compared to a standard review time of the ten months. in the past, FDA  granted Breakthrough Therapy Designation (BTD) for the ripretinib for treatment of the patients with advanced GIST ,received prior treatment with imatinib, sunitinib, and regorafenib.

BTD is designed in order to expedite the development and review of drugs that are projected to treat a serious condition and preliminary clinical evidence indicates that the drug may reveal substantial improvement above available therapy.

The FDA is evaluating the NDA under the pilot program of the Oncology Center of Excellence for Real Time Oncology Review (RTOR).

This pilot program seeks to create a more reliable evaluation process to ensure that patients have access to safe and effective treatments as soon as possible, while preserving and improving the quality of the review.

You can find further information on RTOR at: https:/www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program.

Additionally, the Company has submitted additional marketing applicationsin Canada and Australia Australia for ripretinib in the advanced GIST. These submission are part of the FDA’s pilot program for the Project Orbis, and both received designations for priority review. The Project Orbis pilot programme, an initiative of the FDA Oncology Center of Excellence, is designed to provide a framework for the simultaneous submission and review among international partners of oncology products.You will find additional information concerning Project Orbis at: https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.

The NDA submission is supported by constructive results from the Company’s INVICTUS pivotal Phase 3 study of the ripretinib in advanced GIST. INVICTUS is a randomized (2:1), double-blind, placebo-controlled, international, multicenter study designed in order to evaluate the effectiveness and safety of ripretinib compared to placebo in 129 patients with the advanced GIST whose preceding therapies have included at least imatinib, sunitinib, and regorafenib. As per the report, the study completed its primary endpoint of improved progression-free survival compared to placebo in the patients with fourth-line and fourth-line plus GIST, as determined by the blinded independent central radiologic review using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Ripretinib is an investigational tyrosine kinase switch control inhibitor that was designed to broadly inhibit KIT and PDGFRα mutated kinases by using the unique dual mechanism of action that controls the kinase switch pocket and activation loop. Ripretinib granted Fast Track Designation and Breakthrough Therapy Designation by the FDA for the treatment of the patients with advanced GIST, who have received previous treatment with imatinib, sunitinib, and regorafenib. The FDA also granted Priority Review for the NDA for the ripretinib, and allowed a PDUFA target action date of Aug. 13, 2020. Also, ripretinib granted Orphan Drug Designation for the treatment of GIST by the FDA and European Medicines Agency (EMA). For more information concerning the Company’s clinical trials with ripretinib, please visit www.clinicaltrials.gov.
https://investors.deciphera.com/news-releases/news-release-details/deciphera-pharmaceuticals-announces-us-food-and-drug

U.S.FDA Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application for the Lisocabtagene Maraleucel (liso-cel) for the Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma

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U.S.FDA Accepts for Priority Review Bristol-Myers Squibb’s Biologics License Application for the Lisocabtagene Maraleucel (liso-cel) for the Adult Patients with Relapsed or Refractory Large B-Cell Lymphoma

Feb 13, 2020: U.S.FDA accepted for the Priority Review its Biologics License Application (BLA) for BMS’s lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of adult with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies.

A Prescription Drug User Fee Act (PDUFA) set by FDA as goal date of August 17, 2020.

The BLA, submitted by the Juno Therapeutics, a completely owned subsidiary of BMS, is based on the safety and efficient results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 268 patients with the R/R large B-cell lymphoma, that include diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma.

TRANSCEND NHL 001 is the major study of CD19-directed CAR T cells in order to support a BLA to date and was the new subject of an oral presentation at the 61st American Society of Hematology Annual Meeting and Exposition. A priority review classification, according to the FDA, would concentrate overall attention and resources on reviewing drug applications that, if approved, will substantially improve the
safety or efficacy of treatment, diagnosis, or prevention of severe conditions compared to standard applications. Previously, Liso cel was granted FDA Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations for active R / R major B-cell non Hodgkin lymphoma, like DLBCL, not otherwise defined (de novo or transformed from indolent lymphoma), PMBCL or Grade 3B FL, and Priority Medicines (PRIME) by the European Medicines Agency for R / R DLBCL.
https://news.bms.com/press-release/us-food-and-drug-administration-fda-accepts-priority-review-bristol-myers-squibbs-biol

Merck’s Checkpoint Inhibitor Keytruda (pembrolizumab) Hits Another Mark in Breast Cancer

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Merck’s Checkpoint Inhibitor Keytruda (pembrolizumab) Hits Another Mark in Breast Cancer

Feb 12, 2020: Merck’s checkpoint inhibitor Keytruda (pembrolizumab) proved itself efficient in yet another cancer indication. The company announced positive results from the pivotal Phase III KEYNOTE-355 trial of the Keytruda in combination with chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors uttered PD-L1.

The trial met one of its twin primary endpoints, progression-free survival (PFS). An independent Data Monitoring Committee (DMC) performed interim review of the study, showing that first-line treatment with Keytruda with nab paclitaxel, paclitaxel orgemcitabine/ carboplatin had a statistically significant and clinically significant improvement in PFS relative to chemotherapy alone.

The DMC suggested the trial continue without changes in order to evaluate other dual primary endpoints, which is generally survival (OS).
KETNOYE 355 is a two part Phase III trial which is randomized.Part 1 was openlabel and
 lookedat Keytruda’s protection and tolerability in 30 patients with either nabpaclitaxel, paclitaxel, or gemcitabine/carboplatin.Part 2 was doubleblinded, with double primary OS and PFS endpoints in all participants as well as in participants whose tumours expressed PD-L1. Secondary endpoints comprise objective Response risk (ORR), response time(DOR),disease control rate(DCR), and health.

TNBC is a type of breast cancer which is particularly aggressive. Within the first five years after diagnosis, it has a high rate of recurrence. The triple-negative applies to negative tests of all three hormone receptors, oestrogen receptor, progesterone receptor and receptor of human epidermal growth factor 2 (HER2). Most cancer treatments target one or more of these hormone receptors, and this lack of all three makes the
cancer-targeting difficult for therapies. TNBC affects 15-20percent of women with breast cancer.
https://www.biospace.com/article/merck-s-checkpoint-inhibitor-keytruda-hits-another-mark-in-breast-cancer/



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