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Alexion's Soliris gets full U.S. approval for aHUS

May 6, 2014 12:40 AM UTC

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said FDA granted full approval to Soliris eculizumab to treat atypical hemolytic uremic syndrome (aHUS), a rare and chronic blood disease that can lead to renal failure. The agency granted accelerated approval for Soliris for the indication in 2011. The full approval is based on confirmatory data from two clinical trials, including one in pediatric aHUS patients. The humanized mAb targeting complement 5 (C5) already has full approval in the U.S. to treat paroxysmal nocturnal hemoglobinuria (PNH), another rare blood disorder. ...