Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis
- Positive Phase III trial results support NDA submission, indicating potential efficacy and safety of GA Depot 40 mg for RMS treatment.
- FDA acceptance for review and assignment of PDUFA action date of March 8, 2024, indicates progress in the regulatory process, offering clarity on the timeline for potential approval.
- None.
FDA assigns PDUFA target action date of March 8, 2024
New Drug Application supported by positive Phase III efficacy and safety clinical trial results
Milestone builds upon Viatris' long-standing and continued commitment toward addressing the unmet needs of the MS community
Viatris President Rajiv Malik said, "The NDA filing acceptance for GA Depot is yet another example of our continuous commitment to look for opportunities to enhance existing therapies and innovation to support unmet medical needs. Our application is backed by Phase III efficacy and safety data, and we believe, when approved, GA Depot could improve patient experience through fewer injections, greater tolerability and increased compliance. This milestone gives us further confidence in the strength of our GA Depot clinical program, and we look forward to continuing to work closely with FDA to bring access to this important complex medicine to patients."
According to a landmark study funded by the National Multiple Sclerosis Society, nearly one million people are living with MS in the
The GA Depot NDA filing is supported by results from a multinational, double blind, placebo-controlled Phase III clinical trial evaluating the efficacy, safety and tolerability of GA Depot compared with placebo in patients with RMS. A total of 1,016 subjects were randomized into two groups, receiving either 40mg of GA Depot or placebo, via intramuscular injection (IM), once every 4 weeks for a total of 13 doses. The study concluded that the product offers a preferable schedule and with expected fewer Injection Site Reactions than other GA products. The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate by 30.1 percent compared to placebo (p=0.0066).
"We are confident that GA Depot, when approved, will represent an important advancement in MS care by offering a convenient once-monthly option for patients which may potentially improve compliance and adherence, and the medicine is well positioned to deliver on this important unmet need," said Ehud Marom, CEO and Chairman, Mapi Pharma. "I commend the teams at Mapi and Viatris for the strong collaboration which has leveraged our collective expertise in complex products to deliver this novel medicine."
About GA Depot
GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®), designed to be administered as an intramuscular injection once every four weeks. GA Depot is intended to be used for treatment of Relapsing forms of Multiple Sclerosis (RMS). GA Depot is also currently being tested in Phase II for Primary Progressive Multiple Sclerosis (PPMS).
References:
- https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS/How-Many-People
- https://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris' portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, and a variety of over-the-counter consumer products. With more than 38,000 colleagues globally, Viatris is headquartered in the
About Mapi Pharma
Mapi Pharma is a clinical stage pharmaceutical company, engaged in development of high barrier-to-entry and high added-value life cycle management ("LCM") products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients ("APIs") and formulations. Mapi Pharma partnered with Viatris for GA Depot in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for relapsing forms of multiple sclerosis. The Company is also marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific geographic markets. Mapi's portfolio also includes a leading development of Depot drugs for Schizophrenia, GLP-1 for diabetes, weight control, Parkinson's disease and potentially Alzheimer's with innovative intellectual property. Mapi is built on strong chemical and pharmaceutical R&D capabilities, a deep understanding of the global market and of regulatory needs. Mapi is headquartered in Israel, with R&D facilities in Israel and China, and an API production facility, and an aseptic manufacturing and a Fill & Finish facility for injectable Finished Dosage Forms, all in Israel. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations. For more information, please visit www.mapi-pharma.com.
Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements regarding FDA acceptance of NDA filing for GA Depot for the treatment of relapsing forms of multiple sclerosis; FDA assigns PDUFA target action date of March 8, 2024; the NDA filing acceptance for GA Depot is yet another example of our continuous commitment to look for opportunities to enhance existing therapies and innovation to support unmet medical needs; our application is backed by Phase III efficacy and safety data, and we believe, when approved, GA Depot could improve patient experience through fewer injections, greater tolerability and increased compliance; this milestone gives us further confidence in the strength of our GA Depot clinical program, and we look forward to continuing to work closely with FDA to bring access to this important complex medicine to patients. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that the Company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with acquisitions, divestitures, or its global restructuring program, within the expected timeframe or at all; impairment charges or other losses related to the divestiture or sale of businesses or assets; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by COVID-19; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the
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