Alexion Pharmaceuticals Inc. (ALXN)'s Soliris(R) (Eculizumab) Receives Marketing Approval in Japan for Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
4/16/2010 9:59:14 AM
CHESHIRE, Conn. & LAUSANNE, Switzerland--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Alexion Pharma International Sàrl today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the Company’s New Drug Application (NDA) for the use of Soliris® (eculizumab) as a treatment for patients in Japan with paroxysmal nocturnal hemoglobinuria (PNH). PNH is an ultra-rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris, a first-in-class terminal complement inhibitor, is the first therapy approved in Japan for the treatment of patients with PNH. Soliris received orphan drug designation from the MHLW in 2009 and was approved under the Ministry’s priority review process.
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