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news.The Arthritis Advisory Committee of the US Food and Drug Administration (FDA) has voted 13 to 2 to recommend that the FDA approve Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) Benlysta (belimumab) for the treatment of autoantibody-positive patients with active systemic lupus erythematosus (SLE).
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Generally, 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 9 December 2010.
HGS and GSK claim that 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-commercialisation 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 commercialised under the current agreement.