FDA Approves BLA for MS – Briumvi

The FDA recently approved a biologics license application (BLA) for a new infused therapy, Briumvi from TG Therapeutics, Inc., indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Briumvi is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. CD20 using monoclonal antibodies have proven effective in managing autoimmune disorders such as RMS.

Multiple sclerosis is a neurological disease in which the immune system attacks the brain cells causing physical disabilities.  The National Institutes of Health says that MS affects about 400,000 people in the United States.

The label for Briumvi indicates that there is the potential for serious, life-threatening or fatal, bacterial and viral infections in some Briumvi-treated patients. In MS clinical trials, the overall rate of infections was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in Briumvi-treated patients.

TG Therapeutics did not announce plans for distribution.

Neither did TG Therapeutics confirm pricing at the time of the announcement. Industry analysts differ in their estimates for cost at launch with pricing ranging from a low of $30,000 to as much as $60,000 per patient per year. By comparison, Roche’s Ocrevus, also for MS, has a current list price of about $68,000 annually.

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