FDA approves Benlysta for lupus nephritis.- GlaxoSmithKline

The FDA has given approval of Benlysta (belimumab), from GlaxoSmithKline, as the first-ever treatment indicated specifically for adults with lupus nephritis (LN), a complication of systemic lupus erythematosus (SLE). This new indication is the only FDA approval of a new lupus treatment since belimumab was first approved for systemic lupus erythematosus in 2011. The approval is based on positive results of the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) showing belimumab as a safe and effective therapy for treating lupus nephritis. The Efficacy and Safety of Belimumab in Patients with Active Lupus Nephritis (BLISS-LN) study , involving 448 patients, met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) over two years when treated with belimumab plus standard therapy compared to placebo plus standard therapy in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311). Belimumab also demonstrated statistical significance compared to placebo across all four major secondary endpoints: Complete Renal Response (CRR) after two years (the most stringent measure of renal response), Ordinal Renal Response (ORR) after two years, PERR after one year, and the time to death or renal-related event. In BLISS-LN, safety results for patients treated with belimumab were generally comparable to patients treated with placebo plus standard therapy. The safety results are consistent with the known profile of belimumab.