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Phase III Updates Bode Well For Filings Of Roche's Emicizumab In Hemophilia

 
• By Emily Hayes

Roche believes it can address thrombotic safety issues that cropped up with bispecific antibody emicizumab by providing regulators with guidance on dosing.

3-D Rendering Red Blood Cells

Results from the Phase III HAVEN 1 study published in the New England Journal of Medicine and a positive reception of data presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in Berlin bode well for approval of Roche'semicizumab in hemophilia.

Emicizumab (ACE910) is a bispecific monoclonal antibody that binds to both Factor IXa and X. The drug is being positioned as a convenient, once-weekly subcutaneous therapy and alternative to frequent intravenous injections and infusions for patients who developed inhibitors to factor VIII. (Also see "Roche's Emicizumab Progresses Against Hemophilia's Next Big Challenge: Patients With Factor VIII Inhibitors" - Scrip, 18 April, 2017.) After developing inhibitors, treatment options are more limited and very expensive

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