CHMP recommends Benlysta to treat lupus nephritis- Glaxo Smith Kline

GlaxoSmithKline plc (GSK) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the use of intravenous and subcutaneous Benlysta (belimumab) in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (LN.) The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. If approved, Benlysta would become the first and only biologic approved for both Systemic Lupus Erythematosus (SLE) and LN in the European Union. This CHMP opinion follows the recent label expansion by the FDA to include LN. The CHMP opinion is based on data from the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study and the unmet need in this patient population. The BLISS-LN study is the largest and longest phase III study conducted in active LN, involving 448 adult patients. The study met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response at two years (or 104 weeks) 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). Statistical significance compared to placebo across all four major secondary endpoints was achieved, including Complete Renal Response at Week 104 and Time to Renal-Related Event or Death. The adverse reactions observed in BLISS-LN were consistent with the known safety profile of Benlysta administered intravenously plus standard therapy in patients with SLE.