FDA Arthritis Advisory Committee recommends approval of BENLYSTA for SLE

Nov 17 2010

Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that the Arthritis Advisory Committee of the U.S. 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.

Source : Human Genome Sciences, Inc