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.
“Roche's Hemlibra has been approved in Europe for the treatment of people with haemophilia A with inhibitors.“
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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