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Viatris And Mapi Knocked Back On Once-Monthly US Copaxone Rival

CRL For GA Depot 40mg Means Approval Denied; Are Manufacturing Issues At Play?

 
• By Dean Rudge

Viatris offered little in the way of detail as it announced a setback for its Mapi Pharma-partnered proposed once-monthly glatiramer acetate product for relapsing forms of multiple sclerosis. The firm has previously shouted from the rooftops about Mapi’s Phase III clinical study and the potential to establish a new standard of care for glatiramer acetate patients.

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Viatris and its partner Mapi Pharma will have to wait a little longer before they can move ahead with their proposed once-monthly glatiramer acetate product, a follow-on to Teva’s Copaxone treatment for relapsing forms of multiple sclerosis, after the firms’ ‘GA Depot 40mg’ asset received a US Food and Drug Administration complete response letter.

Viatris offered scant detail on the FDA’s rejection for its application, stating: “The companies are reviewing the content of the CRL and

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