Healthcare company Viatris Inc. (VTRS) and Mapi Pharma Ltd., a late-stage clinical development pharmaceutical company, announced Monday that the U.S. Food and Drug Administration has accepted for review their recently submitted New Drug Application or NDA for GA Depot 40 mg.
GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone). It is being investigated as a once-monthly injection for the treatment of relapsing forms of multiple sclerosis or RMS.
The FDA has assigned a Prescription Drug User Fee Act or PDUFA action date of March 8, 2024.
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.
In the trial, it was 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.
Viatris President Rajiv Malik said, "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."
GA Depot is also currently being tested in Phase II for Primary Progressive Multiple Sclerosis or PPMS.
For More Such Health News, visit rttnews.com
For comments and feedback contact: editorial@rttnews.com
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.