FDA panel backs HGSI's Benlysta for lupus.(Wednesday, Nov. 17)

An FDA panel in a 13-to-2 vote Nov. 16 recommended approval for Rockville, Md.-based Human Genome Sciences Inc.'s Benlysta (belimumab) as a treatment for adults with systemic lupus erythematosus (SLE), a chronic debilitating autoimmune disease that primarily affects women of childbearing age, although men, children and teenagers have been known to develop the condition. Trading of HGSI's shares (NASDAQ:HGSI) was suspended that day pending the panel's votes. if the FDA follows its panel's advice, Benlysta, a recombinant, fully human, IgG1[lambda], monoclonal antibody, would be the first new lupus treatment in more than 50yearstoenterthe U.S. market and the only medicine specifically …