Japan's Chugai notes U.S. FDA breakthrough designation for ACE910

Japan's Chugai Pharmaceutical said the U.S. FDA has granted a breakthrough therapy designation to candidate ACE910 to prevent bleeding episodes in hemophilia A patients aged 12 and older. The compound is in development with Roche's ($RHHBY) Genentech unit, which has development rights outside of Japan, Taiwan, and Korea. "Chugai and Roche plan to initiate a Phase III global study in patients with inhibitors by the end of 2015 and a Phase III global study in patients without inhibitors in 2016." the company said in a release. "Additionally, a trial in pediatric patients with hemophilia A is planned to commence in 2016." Release

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