Benlysta (belimumab) has been approved for adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
H. Thomas Watkins, President and CEO, Human Genome Sciences (HGS), who co-markets the inhibitor with GSK, says the two companies are “honoured” to bring the product to the US.
GSK submitted a Marketing Authorisation Application for Benlysta to the European Medicines Agency in June 2010. Applications have also been submitted, and are currently under consideration, in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.
Moncef Slaoui, Chairman, GSK Research and Development (pictured), 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.”