Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline PLC (GSK) announced that the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve Benlysta (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE).

The FDA Arthritis Advisory Committee is convened to provide the FDA with independent expert advice on a broad range of issues related to rheumatology drug products.  The committee provides non-binding recommendations for consideration by FDA, with the final decision on approval made by FDA.  The FDA has assigned Benlysta a Prescription Drug User Fee Act target date of December 9, 2010.

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors.   HGS and GSK are developing belimumab under a definitive co-development and co-commercialization agreement entered into in 2006.  Under the agreement, HGS has responsibility for conducting the belimumab phase 3 trials, with assistance from GSK. The companies will share equally in phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.