Alexion submits Soliris NDA in Japan

The USA's Alexion Pharmaceuticals has submitted a New Drug Application for Soliris (eculizumab), as a treatment for patients with paroxysmal  nocturnal hemoglobinuria, to Japan's Pharmaceuticals and Medical Devices  Agency.

The NDA included data from AEGIS, an open-label registration study  examining Soliris as a treatment for Japanese patients with PNH relative  to the previously-reported SHEPHERD and TRIUMPH Phase III trials.

The prespecified primary efficacy endpoint of change in hemolysis was  achieved with an 86% reduction (p<0.001). Key secondary endpoints,  including improvement in fatigue (p<0.001) and reduction in transfusions  (p<0.001), were also achieved.