EU CHMP recommends approval of Hemlibra for haemophilia A.- Roche.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hemlibra (emicizumab-kxwh), from Roche, intended to prevent bleeding episodes in patients with haemophilia A who have factor VIII inhibitors. Hemlibra was reviewed under EMA’s accelerated assessment programme.

Hemlibra will be available as a solution for injection (30 mg/1 ml, 60 mg/0.4 ml, 105 mg/0.7 ml and 150 mg/1 ml). Emicizumab is a bispecific monoclonal antibody that mimics the action of factor VIII, preventing bleeding in patients with haemophilia A who have decreased or no circulating levels of factor VIII. The benefits with Hemlibra are its ability to reduce bleeds in routine prophylaxis with a weekly injection.

The most common side effects are headache, injection site reaction, pyrexia, thrombotic microangiopathy, diarrhoea, arthralgia, and myalgia. The full indication is: "Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors. Hemlibra can be used in all age groups."