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Alexion: Subcutaneous ULTOMIRIS Shows PK-based Non-inferiority In Phase 3 Study

Alexion Pharmaceuticals, Inc. (ALXN) announced topline results from a Phase 3 study of weekly self-administered subcutaneous ULTOMIRIS in adults with paroxysmal nocturnal hemoglobinuria. The ongoing study met its primary objective of pharmacokinetic-based non-inferiority of ULTOMIRIS SC versus intravenous ULTOMIRIS at day 71. The company said the study remains ongoing to assess secondary endpoints, including safety, immunogenicity and various PK/PD, quality of life, device performance and efficacy measures.

Alexion now expects to file for approval in the U.S. and E.U. for the ULTOMIRIS SC formulation and device combination in paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the third quarter of 2021.

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