GSK and HGS get approval for lupus drug
London/Rockville - GlaxoSmithKline and its American partner Human Genome Sciences, Inc. announced today that the European Commission has granted marketing authorisation for belimumab (Benlysta) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity (e.g. positive anti-dsDNA and low complement), despite standard therapy. "We and GSK are committed to making Benlysta available in countries worldwide," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "We are particularly honoured to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development." Belimumab received approval from the U.S. FDA on March 9, 2011. GSK and HGS announced approval from Health Canada on July 12, 2011. Regulatory applications have been submitted and are currently under review in Australia, Switzerland, Russia, Brazil, The Philippines, Israel, Singapore, Taiwan and Colombia. HGS and GSK have been working together on belimumab since 2006. Under the agreement, HGS had responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialised under the current agreement.