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Alexion seeks European approval for Soliris to treat rare blood disorder
By Lisa Kerner
Charlotte, N.C., Sept. 26 - Alexion Pharmaceuticals, Inc.'s wholly owned subsidiary, Alexion Europe, has submitted a Market Authorization Application to the European Medicines Evaluation Agency for Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria, a rare, genetic blood disorder.
The Cheshire, Conn., biotechnology included data from its pivotal phase 3 trial, which met all pre-specified primary and secondary endpoints, according to a news release.
Alexion previously submitted a Biologics License Application with the Food and Drug Administration for the drug.
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