First New Lupus Drug Approved in More Than a Half-Century

Benlysta (belimumab) has received FDA approval for the treatment of patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and NSAIDs, the agency announced. This is the first new lupus drug approval in the past 56 years. Previously, the FDA gave approval for hydroxychloroquine and corticosteroids (in 1955) and aspirin (in 1948) to be used for lupus.

Benlysta is delivered via intravenous infusion, the FDA noted. The agent is the first inhibitor designed to target B-lymphocyte stimulator protein, which may reduce the number of abnormal B cells thought to be a problem in lupus. Benlysta was developed by Rockville, Maryland–based Human Genome Sciences Inc, which will comarket the drug in the United States with GlaxoSmithKline of Philadelphia.