Alexion Pharmaceuticals, Inc. (ALXN) announced that the U.S. Food and Drug Administration, or FDA, has granted the company's request for priority review of its supplemental Biologics License Application, or sBLA, for Soliris as a treatment for patients with atypical Hemolytic Uremic Syndrome, or aHUS.
If approval is granted, Alexion anticipates that Soliris would be available for U.S. patients with aHUS in the fourth quarter of 2011. In addition, the European Medicines Agency is reviewing a marketing application for Soliris as a treatment for patients with aHUS in the European Union.
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