European Commission approves Hemlibra, first new hemophilia A treatment in 20 years

The European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.

Hemlibra was originally developed by Roche’s (ROG: SIX) majority-owned Chugai Pharmaceutical (TYO: 4519), with the Swiss pharma giant opting to further develop the drug, which is now approved in Europe for use in all age groups.

Nearly one in three people with severe hemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk of life-threatening bleeds or repeated bleeding episodes that can cause long-term joint damage. People with hemophilia A with inhibitors have a 70% increased risk of death compared to those without inhibitors.