FDA rejects new drug application for intramuscular MS treatment

The FDA has declined to approve a new drug application for GA Depot 40 mg, a long-acting glatiramer acetate under investigation as a once-monthly injection for those with relapsing forms of multiple sclerosis, according to a press release

Viatris Inc. announced that Mapi Pharma Ltd. received a complete response letter from the FDA regarding the NDA. The companies are reviewing its contents and are working to determine the next steps in the process.

The FDA sends a complete response letter when it has decided it will not approve an application.

The press release from Viatris further stated the companies “continue to believe in the potential of the product to provide an important new treatment advancement for patients with MS.”

In August 2023, Viatris and Mapi announced that the FDA accepted the NDA for GA Depot 40 mg and set a Prescription Drug User Fee Act action date of March 8.

The companies submitted the NDA based on results from a multinational, double blind, placebo-controlled, phase 3 clinical trial evaluating safety, efficacy and tolerability of the novel therapeutic.

In the study, more than 1,000 participants were randomized to receive either 40 mg of GA Depot or placebo, via intramuscular injection, once every 4 weeks for a total of 13 doses.

The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate by 30.1% compared to placebo.

Results additionally showed the drug offered a preferable schedule and with expected fewer injection site reactions than other GA products.

Reference:

• Viatris and Mapi Pharma announce FDA acceptance of new drug application filing for GA Depot for the treatment of relapsing forms of multiple sclerosis. https://newsroom.viatris.com/2023-08-07-Viatris-and-Mapi-Pharma-Announce-FDA-Acceptance-of-New-Drug-Application-Filing-for-GA-Depot-for-the-Treatment-of-Relapsing-Forms-of-Multiple-Sclerosis. Posted Aug. 7, 2023. Accessed March 13, 2024.