FDA Panel Overwhelmingly Recommends Approval of Benlysta for Lupus

Despite questions over the drug’s efficacy and safety, an FDA advisory committee has voted 13–2 to recommend approval of Human Genome Sciences and GlaxoSmithKline’s Benlysta to reduce disease activity in adult patients with active, autoantibody-positive systemic lupus erythematosus. Several panelists voiced support for the treatment but noted the drug’s efficacy was mild and not seen in patients of African heritage. If approved by the FDA, Benlysta, a first-in-class, BLyS-specific inhibitor, would likely become the first new lupus therapy to hit the market in more than 50 years.
Drug Industry Daily