Women's Health Weekly
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Alexion Pharmaceuticals, Inc.
Alexion Submits NDA in Japan for Soliris eculizumab as a Treatment for Patients with PNH
April 16th, 2009
Alexion Pharmaceuticals, Inc., (Nasdaq: ALXN) announced that it has submitted a New Drug Application (NDA) for Soliris® (eculizumab) as a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). PNH is a rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. AEGIS Study in Japan The NDA included data from AEGIS, an open-label registration study examining Soliris as a treatment for Japanese patients with PNH. (1) AEGIS was conducted to confirm the safety and efficacy of Soliris in Japanese patients with PNH relative to the previously reported SHEPHERD and...
Source: Women's Health Weekly (2009-04-16)
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