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Human Genome Sciences, GSK Submit Benlysta BLA

Human Genome Sciences, Inc. (HGS) has submitted a BLA to the FDA for approval to market Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Human Genome Sciences, Inc. (HGS) has submitted a BLA to the FDA for approval to market Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE). The BLA submission includes the results from two Phase III trials involving 1,684 patients with autoantibody-positive SLE. In the studies, belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus...

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