FDA grants Breakthrough Therapy Designation for Roche's Hemlibra in haemophilia A without inhibitors

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Hemlibra® (emicizumab-kxwh) for people with haemophilia A without factor VIII inhibitors. Breakthrough Therapy Designation is designed to accelerate the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news