FDA Issues CRL for Monthly MS Drug

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.