Breakthrough designation for Roche, Chugai's ACE910

The Genentech Inc. unit of Roche (SIX:ROG; OTCQXL:RHHBY) and Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said FDA granted breakthrough therapy designation to ACE910 to prevent bleeding episodes in hemophilia A patients aged 12 and older who have Factor VIII inhibitors.

The companies said they plan to start three Phase III trials of ACE910 by YE16, including studies in patients with and without Factor VIII inhibitors and a pediatric trial. ...