Research & Development
The European Commission approves Roche's haemophilia drug Hemlibra
15 March 2019 -

The European Commission has approved Switzerland-based Roche's Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A congenital factor VIII deficiency, it was reported yesterday.

The product can be used in all age groups, and can also now be utilised at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A, including those with factor VIII inhibitors.

The product has received approval based on results from the pivotal HAVEN 3 and HAVEN 4 studies. In the HAVEN 3 study in people with haemophilia A without factor VIII inhibitors, Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis, and compared to prior treatment with factor VIII prophylaxis in a prospective intra-patient comparison.

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