Human Genome Sciences submits BLA for BENLYSTA to FDA

Jun 10 2010

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).

“Our companies will continue to work together to achieve licensure and bring this potentially important new therapeutic option to market. Based on the results of our pivotal Phase 3 studies, HGS believes BENLYSTA could become the first new approved drug for systemic lupus in more than 50 years.”

The BLA submission includes the results of two pivotal Phase 3 clinical trials in autoantibody-positive patients with SLE showing that belimumab met its primary endpoint. In the Phase 3 studies, known as BLISS-52 and BLISS-76, 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 standard of care. Study results also showed that belimumab was generally well tolerated in BLISS-52 and BLISS-76, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups. The design of the two trials was similar, but the duration of therapy in the two studies was different - 52 weeks for BLISS-52 and 76 weeks for BLISS-76. HGS designed the Phase 3 program for belimumab in collaboration with GlaxoSmithKline (GSK) and leading international SLE experts, and in consultation with the FDA. The two studies treated a total of 1,684 patients.

"We and GSK have now submitted regulatory applications for BENLYSTA in both the United States and Europe," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Our companies will continue to work together to achieve licensure and bring this potentially important new therapeutic option to market. Based on the results of our pivotal Phase 3 studies, HGS believes BENLYSTA could become the first new approved drug for systemic lupus in more than 50 years."

Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006. GSK submitted a Marketing Authorization Application for belimumab to the European Medicines Agency (EMA) on June 4, 2010.