FDA panel recommends approval for lupus drug Benlysta

ROCKVILLE, Md. A decision by a Food and Drug Administration advisory committee could pave the way for the first new drug to treat lupus in decades.

The FDA’s Arthritis Advisory Committee voted 13-2 Tuesday to recommend approval for Benlysta (belimumab), a drug for systemic lupus erythematosus made by British drug maker GlaxoSmithKline and U.S.-based Human Genome Sciences, the two companies announced. Lupus is an inflammatory disorder that affects internal organs, joints and skin and, in its severest forms, can be fatal.

Due to the relative paucity of treatments available for the disease, the FDA granted priority review to the drug in August. If approved, Benlysta could become the first new treatment for lupus in more than 50 years.

FDA advisory committee decisions do not guarantee approval, but they are taken into account when the FDA decides whether to approve a drug.