Viatris and Mapi Pharma Report the US FDA Acceptance of NDA for GA Depot to Treat Relapsing Forms of Multiple Sclerosis
Shots:
- The US FDA has accepted the NDA for review of GA Depot (40mg) to treat RMS. The US FDA’s decision is expected in Mar 2024
- The NDA was based on the P-III trial results evaluating the efficacy, safety, and tolerability of GA Depot (IM, q4w for a total of 13 doses) vs PBO in 1016 patients with RMS. The study met its 1EPs & showed that patients treated with GA Depot achieved a significant reduction in the annualized relapse rate by 30.1%
- GA Depot, a long-acting injection version of the approved Glatiramer Acetate which was commercially available as Copaxone. The product is currently being studied in the P-II study for Primary Progressive Multiple Sclerosis (PPMS)
Ref: PRNewswire | Image: Viatris
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