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 And Mapi Knocked Back On Once-Monthly US Copaxone Rival
CRL For GA Depot 40mg Means Approval Denied; Are Manufacturing Issues At Play?
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.
