Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced today that the U.S. Food and Drug Administration (FDA) has granted the Company's request for Priority Review of its supplemental Biologics License Application (sBLA) for Soliris® (eculizumab) as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS). A Priority Review designation is given to drugs that may offer major advances in treatment, or provide a treatment where no adequate therapy exists.
If approval is granted, Alexion anticipates that Soliris would be available for U.S. patients with aHUS in the fourth quarter of 2011. The European Medicines Agency (EMA) is also reviewing a marketing application for Soliris as a treatment for patients with aHUS in the European Union.
Both the US and EU sBLA submissions include the positive data from the 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. Final data from these studies will be presented at the European Hematology Association (EHA) Congress, to be held in London on June 9-12, 2011.
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