SILVER SPRING, Md. — The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.
The FDA approved Benlysta (belimumab), a treatment for systemic lupus erythematosus, the first new treatment for the autoimmune disease in 56 years.
“Benlysta, when used with existing therapies, may be an important new treatment approach for healthcare professionals and patients looking to help manage symptoms associated with this disease,” FDA Office of Drug Evaluation II director Curtis Rosebraugh said.
Prior to Benlysta’s approval, the only drug approved specifically for treating the disease was Sanofi-Aventis’ Plaquenil (hydroxychloroquine) and corticosteroids. Aspirin was approved to treat the disease in 1948.
The approval likely will be a welcome relief for many patients with the disease, a potentially fatal condition in which the body attacks healthy tissues, affecting the joints, skin, kidneys, lungs, heart and brain. Lupus affects between 300,000 and 1.5 million people in the United States.