GlaxoSmithKline (GSK +0.3%) announces positive results from a Phase 3 clinical trial, BLISS-LN, evaluating Benlysta (belimumab) in patients with active lupus nephritis (LN), kidney inflammation caused by systemic lupus erythematosus (SLE), a condition occurring in up to 60% of SLE sufferers.
The study met the primary endpoint showing a statistically significantly greater proportion of patients treated with Benlysta + standard-of-care (SOC) therapy achieving renal response at week 104 compared to those receiving placebo + SOC (43% vs. 32%, p=0.0311).
Key secondary endpoint was also met.
Complete results will be submitted for presentation at future medical conferences and publication.
The company plans to file regulatory applications in H1 2020.
The FDA approved Benlysta for SLE in May 2011.
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