The BLISS-52 study, one of two pivotal Phase 3 trials, was designed to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in autoantibody-positive patients with active SLE.
The double-blind, placebo-controlled, multi-centre superiority study randomised and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe.
The study results have been published in The Lancet.
Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors, which is being developed by HGS and GSK.
The FDA has given Benlysta a Prescription Drug User Fee Act target date of March 10, 2011.