FDA Approves Benlysta for Lupus

Human Genome Sciences, Inc. and GlaxoSmithKline received approval from the FDA for Benlysta (belimumab) for the treatment of autoantibody-positive systemic lupus erythematosus (SLE) in patients receiving standard therapy. Benlysta is the first in a new class of drugs called BLyS-specific inhibitors. Belimumab blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells.

“We and GSK are honored to have the opportunity, with the approval of FDA, to bring Benlysta forward in the U.S. as the first new drug for systemic lupus in more than 50 years,” said H. Thomas Watkins, president and chief executive officer, HGS.

Moncef Slaoui, Ph.D., chairman, GSK R&D, said, “The approval of Benlysta is an important step for appropriate lupus patients. Patients have been waiting for new treatment options to help manage this chronic disease. We look forward to working together with HGS to bring this new medicine to patients in the U.S.”

GSK submitted a MAA for Benlysta to the EMA in June 2010. Regulatory applications have also been submitted in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.