FDA Rejects Viatris, Mapi’s Long-Acting Multiple Sclerosis Injection
PITTSBURGH and NESS ZIONA, Israel, Aug. 7, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the companies' recently submitted New Drug Application (NDA) for GA Depot 40 mg. The product is a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of March 8, 2024.
PITTSBURGH, April 24, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Mapi Pharma today announced that recent data from ongoing studies of GA Depot 40 mg will be presented at the American Academy of Neurology (AAN) 75th Annual Meeting in Boston taking place April 22-27. Data will include results from the pivotal Phase III clinical trial exploring the efficacy and safety of GA Depot – a long-acting glatiramer acetate being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis (RMS).
NESS ZIONA, Israel, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company focused on introducing innovative long-acting depot injectable products, announced today it will host a key opinion leader (KOL) webinar on Glatiramer Acetate (GA) Depot, a potential long-acting injection solution for multiple sclerosis (MS) patients, on Wednesday, October 19, 2022 at 10:30 AM Eastern Time.
NESS ZIONA, Israel, Sept. 21, 2022 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development pharmaceutical company focused on introducing innovative long-acting depot injectable products, announced today positive top-line results from the GA Depot (a long acting glatiramer acetate) Phase III clinical trial assessing the efficacy, safety and tolerability of a once monthly GA Depot 40 mg compared to placebo in relapsing forms of multiple sclerosis (RMS) patients. Top-line efficacy results showed that GA Depot 40 mg meet the primary endpoint versus placebo in significantly reducing the ARR. The one-year multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo-controlled study in subjects with relapsing forms of multiple sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, IM injection once monthly recruited 1,016 patients at 112 multinational sites.
NESS ZIONA, Israel, March 31, 2022 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting...
NESS ZIONA, Israel, March 30, 2022 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting...
DUBAI, United Arab Emirates and NESS ZIONA, Israel, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd. (“Mapi” or the “Company”), a developer of high-barrier to entry and high value-added generic drugs that include complex active pharmaceutical ingredients (“APIs”), formulations and life cycle management (“LCM”) products that target large markets, announced that it has entered new Middle Eastern markets with the signing of a distribution agreement granting Gaelan Medical Trade LLC, the healthcare arm of the Ghassan Aboud Group (GAG), an international conglomerate based in the United Arab Emirates (UAE), an exclusive right to market and distribute Mapi products in UAE.
NESS ZIONA, Israel, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a fully integrated, late clinical stage biopharmaceutical company, today announced that patient enrollment has surpassed 60% in the ongoing GA Depot (glatiramer acetate) Phase III trial for Relapsing forms of Multiple Sclerosis (RMS).
NESS ZIONA, Israel – Dec. 21, 2020 – Mapi Pharma Ltd., a fully integrated, late clinical stage biopharmaceutical company, today announced that patient enrollment has surpassed 60% in the ongoing GA Depot (glatiramer acetate) Phase III trial for Relapsing forms of Multiple Sclerosis (RMS).