BioCentury
ARTICLE | Company News

FDA approves subcutaneous Benlysta formulation

July 21, 2017 7:40 PM UTC

FDA approved a subcutaneous formulation of 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 FDA has approved to treat SLE.

FDA approved Benlysta's IV formulation in 2011, making it the first new lupus drug to be approved in 56 years. GSK VP of Immunology and Rare Disease Sheri Mullen told BioCentury the biologic has treated 36,000 U.S. patients to date, with double-digit growth each year since its launch...

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BLyS (BAFF) (TNFSF13B)