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Alexion Pharmaceuticals Inc announces FDA approves conversion of Soliris (eculizumab) accelerated approval in aHUS to regular approval for treatment of patients with aHUS

Monday, 5 May 2014 06:30am EDT 

Alexion Pharmaceuticals Inc:FDA has approves company's supplemental Biologics License Application (sBLA) providing regular approval for Soliris (eculizumab) for treatment of adult and pediatric patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA).This update reflects Alexion's fulfillment of post-marketing requirements, including submission of confirmatory data from two additional prospective clinical trials, including one in pediatric patients with aHUS.Revised label specifies important longer-term clinical benefit associated with chronic and sustained Soliris treatment with inclusion of results with two years of ongoing treatment in aHUS patients.Updated label also includes data on use of Soliris treatment prior to use of supportive care with either plasma exchange or plasma in prospective clinical trials. 

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