FDA slaps CRL on Viatris and Mapi NDA

12 March 2024

USA-based Viatris (Nasdaq: VTRS) said in a website posting that it has been informed by its partner, Israel-based Mapi Pharma, that it has received a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for GA Depot 40mg from the US Food and Drug Administration (FDA).

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 companies are reviewing the content of the CRL and will be determining the appropriate next steps. The companies continue to believe in the potential of the product to provide an important new treatment advancement for patients with multiple sclerosis.

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