Glaxo, Human Genome Get Fast Review for Lupus Drug

FDA move means Benlysta could be approved by Dec. 9

Thursday, August 19, 2010

(Reuters) - A keenly awaited new lupus drug from GlaxoSmithKline and Human Genome Sciences Inc will get a priority review from U.S. regulators, potentially clearing the way for its approval by mid-December.

If approved, Benlysta will be the first new drug in more than 50 years for systemic lupus -- a complex disease that causes the immune system to attack the body's own tissue and organs.

The priority review from the Food and Drug Administration means the drug, which is also known as belimumab and was submitted to the agency on June 9, should be reviewed in six months rather than the normal 10.

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