Maharishi Ayur-products International: Viatris and Mapi evaluate next steps after FDA rejects long-acting MS injection

The FDA handed down a complete response letter to Viatris and Mapi Pharma for their long-acting injection for the treatment of relapsing forms of multiple sclerosis, the companies announced Monday. In a statement with few details, the companies said they are reviewing the CRL and will be "determining the appropriate next steps," adding that they "continue to believe in the potential of the product to provide an important new treatment advancement for patients with multiple sclerosis." Viatris said that the rejection doesn't change its 2024 financial guidance or its new product revenue range of $450 million to $550 million. The companies' drug, known as GA Depot, is a once-monthly injection of glatiramer acetate, which is already commercially available as Copaxone but as an injection three times a week. Teva owns Copaxone and reported $78 million in revenue in the US in the final quarter of 2023, a 24% decline from the same period in 2022, which Teva attributed to generic competition and other therapies for multiple sclerosis outside of glatiramer acetate. The FDA originally accepted Viatris and Mapi's NDA in August 2023 based on a 1,016-patient Phase III trial that compared the injection to a placebo. In the study, patients were given the injection once a month for 13 cycles. The trial met its primary endpoint showing that the injection "statistically significantly reduced" the yearly relapse rate by 30.1% compared with placebo (p=0.0066). GA Depot is also in a Phase II study for patients with primary progressive multiple sclerosis.