FDA approves GSK's subcutaneous Benlysta for SLE

FDA approved subcutaneous Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat systemic lupus erythematosus (SLE). GSK said the human mAb against BLyS (BAFF; TNFSF13B) is the first subcutaneous, self-injectable therapy that FDA has approved to treat SLE.

FDA approved Benlysta's IV formulation in 2011, making it the first new lupus drug approved in 56 years. GSK said the biologic has treated 36,000 U.S. patients to date, with double-digit growth each year since its launch, and that the subcutaneous form would give patients and physicians a weekly, self-administered alternative to the monthly IV dose...