FDA grants Priority Review to Roche ’s Hemlibra for people with haemophilia A without factor VIII inhibitors

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Hemlibra® (emicizumab-kxwh) for adults and children with haemophilia A without factor VIII inhibitors. The sBLA is based on data from the phase III HAVEN 3 study.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured Roche Business and Industry Source Type: news