FDA Delays Approval of GA Depot 40mg/mL (glatiramer acetate) Monthly Injection for Relapsing Forms of MS
March 11, 2024
The U.S. Food and Drug Administration has declined to approve GA Depot 40mg/mL (glatiramer acetate, Viatris) which is a long-acting injection version of glatiramer acetate (Copaxone®, Teva and Glatopa®, Sandoz). It is designed to be administered as an intramuscular injection once every four weeks for relapsing forms of MS. Viatris received a Complete Response Letter (CRL) from the FDA which means the FDA is requiring more information from Viatris in order for the FDA to consider approval.
According to a company press release, Viatris will review the content of the CRL and will determine appropriate next steps.
Copaxone is a registered trademark of Teva
Glatopa is a registered trademark of Sandoz
Multiple sclerosis is an unpredictable disease of the central nervous system. Currently there is no cure. Symptoms vary from person to person and may include disabling fatigue, mobility challenges, cognitive changes, and vision issues. An estimated 1 million people live with MS in the United States. Early diagnosis and treatment are critical to minimize disability. Significant progress is being made to achieve a world free of MS.
The National MS Society, founded in 1946, is the global leader of a growing movement dedicated to creating a world free of MS. The Society funds cutting-edge research for a cure, drives change through advocacy and provides programs and services to help people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, X, formerly known as Twitter, Instagram, YouTube or 1-800-344-4867.