ROCKVILLE, Md. An investigational drug for lupus that could become the first new treatment for the disease in decades produced significant results in patients, compared with standard treatments, according to results of a late-stage clinical trial set for presentation Saturday.
GlaxoSmithKline and Human Genome Sciences said Thursday that Benlysta (belimumab) significantly reduced symptoms of systemic lupus erythematosus when added to standard treatments compared with standard treatments alone in the placebo-controlled phase 3 “BLISS-52” study. Results of the study will be presented at the 2010 Congress of the European League against Rheumatism.
“The BLISS-52 phase 3 results presented at EULAR demonstrate that the efficacy of treatment in this study with belimumab plus standard of care was superior to that of placebo plus standard of care,” HGS EVP research and development David Stump stated. “Belimumab has met the primary endpoint in both of its pivotal phase 3 trials.”
Based on the results, HGS and GSK have submitted regulatory approval applications for the drug. If approved, it could become the first new treatment in more than 50 years for lupus, a potentially life-threatening disease that affects around 1.5 million Americans and 5 million people worldwide.