Roche’s Hemlibra receives EU approval for haemophilia A with inhibitors

Roche has announced that its haemophilia therapy Hemlibra has been approved by the European Commission.

The regulator has approved Hemlibra for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors, with all age groups eligible to use the therapy.

Nearly one in three people with severe haemophilia A can develop inhibitors to factor VIII replacement therapies, meaning they are at greater risk of life-threatening bleeds or repeated bleeding episodes, as well as a 70 percent increased risk of death.

This approval was based the findings of two of the largest pivotal clinical studies in people with haemophilia A with inhibitors, in which Hemlibra demonstrated superior efficacy compared to prior treatment with bypassing agents.

Dr Sandra Horning, Roche's chief medical officer and head of global product development, said: "We believe Hemlibra has the potential to make a meaningful difference in the lives of people with haemophilia A with inhibitors, and are committed to working with EU member states to provide access to this important medicine as quickly as possible."

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