FDA Issues CRL for Monthly MS Drug
GA Depot is a once-monthly injection to treat patients with relapsing forms of multiple sclerosis. No information was provided for why the FDA issued a complete response letter.
The FDA has issued a complete response letter (CRL) for the new drug application (NDA) for GA Depot 40 mg to treat patients with relapsing forms multiple sclerosis. No information has been provided for why the FDA would not approve the application.
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.
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.
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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