FDA Sets PDUFA Date for Monthly MS Drug
The FDA has assigned a March 8, 2024, action date for GA Depot, a once-monthly injection to treat patients with relapsing forms of multiple sclerosis.
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.
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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