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Roche and Chugai's Hemlibra scoops up EU approval in the prevention of severe haemophilia A without factor VIII inhibitors

Published on 14/03/19 at 10:53am

Roche has announced along with its partner Chugai that Hemlibra (emicizumab) has secured approval from the European Commission as a preventative treatment for bleeding episodes in patients with severe haemophilia A without factor VIII inhibitors.

The drug is suitable for use in any age of patient and can be self-administered via subcutaneous injection every one, two or four weeks. It already held authorisation for the treatment of haemophilia A with factor VIII inhibitors

The latest decision was made on the back of Phase 3 data indicating that the drug reduced bleeds by 96% and 97% when administered once or twice weekly respectively, compared to FVIII treatment given on-demand.

“People with severe haemophilia A face many challenges in managing their condition, requiring regular infusions to reduce their risk of bleeding.  There has been a need to expand the treatment options for bleed prevention,” commented Dr Dan Hart, consultant haematologist from The Royal London Hospital Haemophilia Centre. “As current treatments can require intravenous infusions multiple times a week this can place a significant burden on people with the condition and their families. This new, effective treatment option will give those affected greater choice and hopefully allow many to live more freely.”   

Richard Eaton, Rare Diseases Lead at Roche UK, added: “We believe Hemlibra is a much-needed treatment option which can have a positive impact on those living with haemophilia A today. Our main focus now is securing NHS reimbursement so that those in need get access as soon as possible. We are working closely with NHS England, as well as each of the devolved nations, to achieve this most urgently.”

Matt Fellows

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