Women's Health Weekly
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Alexion Pharmaceuticals, Inc.
Soliris Receives Orphan Drug Designation in Japan
January 29th, 2009
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) reported that Soliris(R) (eculizumab), its first-in-class complement inhibitor, has been designated as an orphan drug by the Ministry of Health, Labour and Welfare of Japan. As a result of the designation, a New Drug Application (NDA) for Soliris would receive priority review from the Japanese regulatory authorities once it is submitted, and the drug would have 10 years of market exclusivity as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) in Japan. Soliris was previously granted orphan drug status in the United States and European Union, and has been in use in the U.S. and European countries...
Source: Women's Health Weekly (2009-01-29)
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