FDA approves Hemlibra for hemophilia A with inhibitors

The US Food and Drug Administration has approved Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors.

The drug was developed by Genentech and parent company Swiss pharma giant Roche (ROG: SIX), which points out that this is the first new medicine in nearly 20 years to treat people with hemophilia A with inhibitors.

The FDA decision comes considerably sooner than the previously mentioned date of February 23, 2018.