26 January 2018 - Hemlibra demonstrated superior efficacy compared to prior treatment with bypassing agents in two phase III studies across age groups.

Roche today announced that the EU CHMP has adopted a positive opinion for Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors. The CHMP has recommended Hemlibra for use in all age groups. Nearly one in three people with severe haemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk of life-threatening bleeds or repeated bleeding episodes that can cause long-term joint damage. 

The Hemlibra marketing authorisation application is being reviewed under accelerated assessment, a procedure granted to medicines that the CHMP believes are of major interest for public health and therapeutic innovation. Based on the positive CHMP recommendation, a final decision regarding the approval of Hemlibra is expected from the European Commission in the near future.

Read Roche press release