US FDA declines to approve Viatris’s injection for multiple sclerosis
US FDA declines to approve Viatris’s injection for multiple sclerosis
March 11 (Reuters) – The U.S. FDA has declined to approve Viatris (VTRS.O) and Mapi Pharma’s once-a-month injection for treating relapsing forms of debilitating neurological condition multiple sclerosis (MS), the companies said on Monday.
The companies were reviewing the content of the health regulator’s so called complete response letter (CRL) and would soon determine the appropriate next steps, they said, without disclosing further details.
Mapi Pharma did not immediately respond to Reuters requests for additional details on the contents of the CRL, which indicates that an application would not be approved in its present form and requires more information.
The companies were seeking the FDA’s nod for GA Depot, a long-acting version of glatiramer acetate, which is approved for relapsing forms of MS.
GA Depot was being studied to be administered as an intramuscular injection once every four weeks, where as Teva Pharmaceutical Industries’ (TEVA.TA) glatiramer acetate injection, Copaxone, is given thrice a week.
Reuters
