GSK submits BENLYSTA MAA for systemic lupus erythematosus

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that GlaxoSmithKline (GSK) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).

“Based on the results of our pivotal Phase 3 studies, we believe BENLYSTA has the potential to become the first new approved drug for systemic lupus in more than 50 years”

The MAA 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 GSK and leading international SLE experts. The two studies treated a total of 1,684 patients.

"Based on the results of our pivotal Phase 3 studies, we believe BENLYSTA has the potential to become the first new approved drug for systemic lupus in more than 50 years," said H. Thomas Watkins, President and Chief Executive Officer, HGS. Mr. Watkins also said that HGS and GSK plan to submit a Biologics License Application to the U.S. Food and Drug Administration later in June.