FDA Sets PDUFA Date for Monthly MS Drug

The FDA has accepted the new drug application for GA Depot (glatiramer acetate) to treat patients with relapsing forms multiple sclerosis, and assigned a PDUFA action date of March 8, 2024.

Multiple sclerosis impacts the brain and spinal cord. In MS, the immune system attacks myelin, the protective layer of nerve fibers. It causes problems with vision, arm and leg movement and balance. According to the National Multiple Sclerosis Society, nearly 1 million people are living with MS in the United States, and about 85% are initially diagnosed with the relapsing-remitting form of the disease.

Developed by Viatris and Mapi Pharma, GA Depot is a long-acting version of glatiramer acetate, which is available as generics and as the branded therapy Copaxone. Glatiramer acetate stops the immune system from attacking myelin. Available glatiramer acetate therapies involve injections three times a week, whereas GA Depot would be administered once every four weeks.

The NDA is supported from results from a phase 3 clinical trial evaluating the efficacy, safety and tolerability of GA Depot compared with placebo in 1,016 patients with relapsing multiple sclerosis. The trial that GA Depot offers a preferable schedule and with expected fewer injection site reactions than other GA products. The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate by 30.1% compared with placebo.

The data were presented recently at the American Academy of Neurology (AAN) annual meeting in April 2023.