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FDA accepts Bioverativ’s investigational new drug application for BIVV001

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The FDA accepted the investigational new drug application for BIVV001, according to the agent’s manufacturer.

BIVV001 (Bioverativ) is a novel, investigational Factor VIII therapy designed to extend protection from bleeds in patients with hemophilia A.

“People with hemophilia A continue to have a strong unmet need for therapies that can provide protection from bleeds and favorable long-term outcomes in terms of joint health and quality of life with once-weekly dosing,” Tim Harris, PhD, DSc, executive vice president of research and development at Bioverativ, said in a company-issued press release. “In 2014, we made significant progress toward this goal with the introduction of Eloctate, the leading extended half-life therapy for hemophilia A. This investigational new drug acceptance expands on that legacy and reflects our continued commitment to advancing scientific innovation that can make a meaningful difference for people with hemophilia.”

BIVV001 is the only investigational Factor VIII therapy in development that is designed to overcome the von Willebrand factor ceiling, which likely imposes a half-life limitation on Factor VIII therapies.

“BIVV001 is the first molecule of its kind to fuse four different proteins together to address the challenges of hemophilia A,” Rob Peters, PhD, senior vice president of research at Bioverativ, said in the release. “We are encouraged by our extensive preclinical data which show improved pharmacokinetics that are independent of von Willebrand factor, and look forward to commencing our [phase 1/phase 2a] clinical trial later this year.”