Roche’s Drug Hemlibra Gets Breakthrough Designation for Hemophilia A Indication

The FDA granted a breakthrough designation to Roche’s drug Hemlibra (emicizumab-kxwh) for treatment of hemophilia A patients without factor VIII inhibitors.

The FDA granted the designation based on Phase III trial data showing no thrombotic microangiopathy or thrombotic events.

The FDA approved the drug for treatment of hemophilia A patients with factor VIII inhibitors last November.