Alexion Pharmaceuticals announced that the FDA has granted priority review of its supplemental Biologics License Agreement (sBLA) for Soliris (eculizumab) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). The sBLA submission includes positive data from two 26-week Phase 2 studies of Soliris as a treatment for adult and adolescent patients with aHUS. Primary endpoints in both studies were achieved with statistical significance. If approval is granted, Alexion anticipates that Soliris would be available for U.S. patients with aHUS in the fourth quarter of 2011.
Soliris is a terminal complement inhibitor, currently approved for patients with paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, debilitating and life-threatening blood disorder defined by chronic uncontrolled complement activation, which causes chronic hemolysis, leading to blood clots, organ failure, and shortened survival.
For more information call (888) SOLIRIS or visit www.soliris.net.