Roche said on Friday it had won breakthrough therapy designation from the U.S. Food and Drug Administration for an experimental haemophilia medicine, aiming for a piece of the $11 billion haemophilia drug market.
The Swiss drugmaker said its U.S.-based Genentech unit’s ACE910 secured the fast-track designation as the company prepares separate Phase III trials in 2015 and 2016, the first in patients with haemophilia A with factor VIII inhibitors and the second for patients without inhibitors.