Alexion Pharmaceuticals, Inc. (ALXN) said it has submitted marketing applications to the U.S. Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, for Soliris as a treatment for patients with atypical Hemolytic Uremic Syndrome, or aHUS.
The company specified that both the US and EU filings include the positive data from the two 26-week Phase 2 studies of Soliris as a treatment for adult and adolescent patients with aHUS.
Further, Alexion raised its fiscal-2011 revenue forecast to the range of $720 to $740 million from the previously announced range of $715 to $735 million. Analysts anticipated revenues of $735.54 million for the year.
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