GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. announced publication of the BLISS-52 study of Benlysta® (belimumab) in autoantibody-positive patients with active systemic lupus erythematosus (SLE) in The Lancet. The BLISS-52 study, one of two pivotal Phase III trials, was a double-blind, placebo-controlled, multi-centre superiority trial 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. BLISS-52 randomised and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. The Phase III programme for belimumab is the largest clinical programme ever conducted in patients with SLE.
A Comment accompanying The Lancet article was authored by John H. Stone, M.D., of Massachusetts General Hospital and Harvard Medical School.
Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. It is being developed by GSK and HGS under a co-development and commercialisation agreement entered into in 2006. The FDA has assigned Benlysta a Prescription Drug User Fee Act target date of 10 March, 2011.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com. GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.
Human Genome Sciences – exists to place new therapies into the hands of those battling serious disease.
For more information about HGS, please visit the Company’s web site at www.hgsi.com.
