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news.Human Genome Sciences (HGS) has submitted a biologics license application (BLA) to the FDA for approval to market Benlysta (belimumab) for the treatment of systemic lupus erythematosus (SLE).
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HGS said that 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.
Belimumab is being developed by HGS and GSK under a co-development and commercialisation agreement entered into in 2006. GSK submitted a marketing authorisation application for Belimumab to the European Medicines Agency (EMA) on June 4, 2010.
In the Phase 3 studies, known as Bliss-52 and Bliss-76, Belimumab 10mg/kg plus standard of care achieved improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.
The study results also showed that Belimumab was generally well tolerated in Bliss-52 and Bliss-76. 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.
Thomas Watkins, president and CEO of HGS, said: “We and GSK have now submitted regulatory applications for Benlysta in both the US and Europe. 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.”