WASHINGTON (dpa-AFX) - Alexion Pharmaceuticals, Inc. (ALXN), on Friday, announced the U.S. FDA approved ULTOMIRIS for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria, an ultra-rare blood disorder characterized by complement-mediated destruction of the red blood cells. The approval comes ahead of the PDUFA date of February 18, 2019, set by the FDA as part of an expedited eight month review.
The company noted that regulatory authorities in the EU and Japan are reviewing applications for the approval of ULTOMIRIS as a treatment for adults with paroxysmal nocturnal hemoglobinuria.
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