Viatris, Mapi Pharma: FDA Accepts For Review NDA For GA Depot To Treat RMS

(RTTNews) - 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.

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