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Roche hemophilia drug Hemlibra wins EU nod

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Roche hemophilia drug Hemlibra wins EU nod

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.