GlaxoSmithKline (GSK) and Human Genome Sciences, Inc. (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 auto-antibody-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 III studies of belimumab (BLISS-52 and BLISS-76), which enrolled nearly 1700 adult patients with auto-antibody-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, PhD, 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.”

Belimumab is the first in a new class of drugs called BLyS-specific inhibitors. Belimumab received approval from the US 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.

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 III trials, with assistance from GSK. The companies share equally in phase III/IV development costs, sales and marketing expenses, and profits of any product commercialised under the current agreement.

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