EC extends license for Roche/Chugai’s Hemlibra
The European Commission has approved Roche and Chugai Pharma UK’s Hemlibra for the prevention of bleeding episodes in people with severe haemophilia A without factor VIII inhibitors, expanding the drug’s treatment scope.
Hemlibra (emicizumab) can be self-administered by injection under the skin at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people of any age with haemophilia A.
The decision follows results of the Phase III HAVEN 3 study, in which adults and adolescents aged 12 years or older without factor VIII inhibitors who received Hemlibra prophylaxis every week or every two weeks showed a 96 percent and 97 percent reduction in treated bleeds, respectively, compared to those who received no prophylaxis.
In addition, 55.6 percent of people treated with Hemlibra every week and 60 percent of those given the drug every two weeks experienced zero treated bleeds, compared to 0 percent of people treated with no prophylaxis.
On the safety side, there were no unexpected or serious adverse events (AEs) related to the therapy observed in the study, the most common being injection site reactions, joint pain, common cold symptoms, headache, upper respiratory tract infection and influenza.
“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,” said 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 said, the firm’s main focus now will be “securing NHS reimbursement so that those in need get access as soon as possible,” and that it is “working closely with NHS England, as well as each of the devolved nations, to achieve this most urgently.”
Hemlibra is already available as a treatment option for people with haemophilia A with inhibitors to factor VIII.
14th March 2019
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