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FDA extends Benlysta PDUFA date

December 4, 2010 1:17 AM UTC

FDA extended the PDUFA date by three months for a BLA from Human Genome Sciences Inc. (NASDAQ:HGSI) for Benlysta belimumab to March 10, 2011, from Dec. 9. The human mAb against BLyS (B lymphocyte stimulator protein) is under Priority Review to treat systemic lupus erythematosus (SLE). Human Genome said FDA needs time to consider undisclosed additional information submitted by the company at FDA's request.

Last month, an FDA advisory committee voted 13-2 in favor of approving Benlysta. However, panel members who voted 'yes' felt the label should reflect the populations studied in Phase III trials, which excluded patients with severe lupus nephritis or CNS manifestations of the disease. ...