The European Commission approved Swiss group Roche Holding AG's hemophilia A drug Hemlibra to treat patients who have developed resistance to other treatments.
Hemophilia A is an inherited disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. People with the disorder either lack or do not have enough of a clotting protein called factor VIII.
Hemlibra, or emicizumab, aims to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A with antibodies that block factor VIII replacement therapies.
The approval was backed by data from two clinical trials.
In the first trial, Hemlibra cut the bleed rate by 87% in adults and adolescents with the disease versus those who did not receive treatment. In the second trial, 87% of the children taking the drug did not experience a bleeding episode that required treatment.
Hemlibra is already approved in the U.S.