GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (Nasdaq: HGSI) announced 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.
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 commercialisation team in Europe and, assuming a positive European Commission decision, we look forward to working alongside GSK to make Benlysta available to patients."
About Benlysta (belimumab)
Belimumab is the first in a new class of drugs called BLyS-specific inhibitors. Belimumab received approval from the U.S. Food and Drug Administration (FDA) on 9th March, 2011. Regulatory applications have been submitted and are currently under review in Canada, Australia, Switzerland, Russia, Brazil, The Philippines, Israel and Colombia.
About the GSK/HGS collaboration
GSK and HGS are developing belimumab under a definitive co-development and co-commercialisation agreement entered into in 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.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Biopharm R&D is employing novel approaches to harness the therapeutic potential of biopharmaceuticals for the benefit of patients with serious autoimmune disease.
Human Genome Sciences exists to place new therapies into the hands of those battling serious disease. HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.