Alexion Pharmaceuticals, Inc. today reported that Soliris (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 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.
The details can be read here.
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