Japan approves Alexion's Soliris for aHUS

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said Japan's Ministry of Health, Labor and Welfare (MHLW) approved an sNDA for Soliris eculizumab to treat atypical hemolytic uremic syndrome (aHUS). Alexion expects aHUS patients in Japan to begin treatment with Soliris next quarter. The humanized mAb targeting complement 5 (C5) is already approved in Japan to treat paroxysmal nocturnal hemoglobinuria (PNH). Soliris is also approved in the EU and U.S. for aHUS, and in over 40 countries, including the EU, to treat PNH. Both are rare, genetic blood disorders. ...