The US FDA Rejects Viatris’s Injection for Multiple Sclerosis

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The US FDA Rejects Viatris's Injection for Multiple Sclerosis

The U.S. Food and Drug Administration (FDA) has declined to approve Viatris and Mapi Pharma’s once-a-month injection intended for treating relapsing forms of multiple sclerosis (MS), a debilitating neurological condition, the companies announced on Monday.

Both companies are currently reviewing the content of the FDA’s complete response letter (CRL), a communication indicating that the application would not be approved in its current state and necessitates additional information. However, specific details regarding the contents of the CRL have not been disclosed yet.

Mapi Pharma, in particular, has not immediately responded to requests from Reuters for further information regarding the contents of the CRL.

The joint application sought FDA approval for GA Depot, a long-acting version of glatiramer acetate, which is already approved for treating relapsing forms of MS. GA Depot was designed to be administered as an intramuscular injection once every four weeks, offering a less frequent dosing regimen compared to existing treatments like Teva Pharmaceutical Industries’ glatiramer acetate injection, Copaxone, which is administered thrice a week.

Viatris gained commercialization rights to GA Depot through an exclusive license agreement with Mapi Pharma in 2018.

Despite the setback from the FDA, Viatris affirmed that the receipt of the complete response letter would not affect its 2024 forecast or the projected revenue range of $450 million to $550 million from new products.

MS is characterized by the immune system attacking brain cells, resulting in motor disabilities. It affects approximately 400,000 individuals in the United States, as reported by the National Institutes of Health. Relapsing MS is a subtype of the disease marked by sporadic symptom flare-ups, followed by periods of remission where the disease remains inactive for varying lengths of time before another relapse occurs.