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Roche's haemophilia A drug shows meaningful bleed control in P3

Published on 07/12/17 at 09:47am

Roche has unveiled new Phase 3 data for its haemophilia A treatment Helimbra (emicizumab) in patients over 12 years of age with the condition without inhibitors to factor VIII, showing that the prophylaxis therapy produced clinically meaningful control of bleeding when used once every four weeks.

Helimbra, a bispecific factor IXa- and factor X-directed antibody, was tested in 48 haemophilia A patients with or without inhibitors to factor VIII or bypassing agents, on-demands or as prophylaxis. The new data proved consistent with earlier studies of the drug in doses of once weekly or every two weeks.

Full data from the study is due to be presented at an upcoming medical meeting, with authorisation applications in global markets to follow.

“Current treatment regimens for haemophilia A can require frequent intravenous infusions. We are encouraged that Hemlibra prophylaxis administered by injection under the skin once every four weeks showed clinically meaningful bleed control in people with haemophilia A,” commented Sandra Horning, Chief Medical Officer and Head of Global Product Development at Roche. “Together with the findings from other phase III studies, these interim results support the potential for Hemlibra to be dosed at different schedules, allowing patients to choose the option that’s right for them.”

Matt Fellows

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