EMA CHMP issues positive opinion for marketing approval of BENLYSTA

May 20 2011

GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for BENLYSTA^® (belimumab) 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. We are well along in building our own HGS commercialization team in Europe and, assuming a positive European Commission decision, we look forward to working alongside GSK to make BENLYSTA available to patients.”

The CHMP is responsible for conducting the assessment of medicines for which an EU-wide marketing authorisation is sought. As part of its assessment to determine whether or not belimumab meets the necessary quality, safety and efficacy requirements, the CHMP reviewed data from two pivotal Phase 3 studies of belimumab (BLISS-52 and BLISS-76), which enrolled nearly 1700 adult patients with autoantibody-positive active systemic lupus erythematosus. The final decision regarding approval rests with the European Commission; this decision is normally issued approximately two-to-three months after the CHMP opinion.

"A positive recommendation from the CHMP is a major milestone in the clinical development programme for BENLYSTA. We look forward to the final decision from the European Commission regarding marketing authorisation and hope to bring this new medicine to appropriate patients in Europe," said Moncef Slaoui, Ph.D., Chairman, GSK Research and Development.

H. Thomas Watkins, President and Chief Executive Officer, HGS, said, "We and GSK are committed to making BENLYSTA available in countries worldwide. We are well along in building our own HGS commercialization team in Europe and, assuming a positive European Commission decision, we look forward to working alongside GSK to make BENLYSTA available to patients."