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news.Alexion Pharmaceuticals, a biopharmaceutical company which develops and commercializes life-transforming therapeutic products, has filed marketing applications with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for atypical Hemolytic Uremic Syndrome (aHUS) treatment - Soliris (eculizumab).
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The company has filed the marketing applications on the basis of the results from two 26-week Phase 2 studies evaluating Soliris as a treatment for adult and adolescent patients with aHUS.
Both the triasl showed positive results and have achieved primary endpoints with statistical significance.
Alexion Pharma CEO Leonard Bell said they recognize that patients with aHUS, lack adequate treatment options, and they look forward to working with regulatory authorities as they review their applications.