Human Genome Sciences Inc. (HGSI) and GlaxoSmithKline PLC (GSK)announced that BENLYSTA met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus.
The company said BLISS-76 study results through 52 weeks showed that 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.
The company stated that study results also showed that belimumab was generally well tolerated, 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.
Human Genome Sciences stated that the BLISS-76 results confirm its view that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus. The company plans to submit marketing applications in the first half of 2010.
The BLISS-76 study is ongoing and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period.
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