Benlysta may become first new lupus drug in 50 years

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For the first time in 50 years, a new drug to treat lupus seems on the verge of coming onto the market. An FDA panel has voted 13-2 to recommend approval of Benlysta, used to treat sytemic lupus erythematosus (SLE, or lupus), an autoimmune condition. The drug, developed by Human Genome Sciences and GlaxoSmithKline, is an immunosupressant therapy designed to treat pain and flare-up symptoms associated with lupus — a potentially serious, or even fatal disease whose victims are mostly women. It can cause skin rashes, joint pain, and inflammation of the kidneys and tissue surrounding the heart. Some of the clinical trials, however, showed that certain patient populations, particularly African-Americans — who often experience a more severe form of the disease — do not benefit from the new therapy.

Despite the drug’s limited benefit to certain patient populations and its possible side-effects, it still has “the potential to substantially improve the quality of life for many lupus patients, who have few good treatment options,” says ACSH's Dr. Gilbert Ross, who was a rheumatologist when in practice, and dealt with SLE often.

The FDA is scheduled to make a final decision on Benlysta by December 9th, and the drug could become available before March 2011.