Genentech Phase III HAVEN 3 study results published in NEJM

Genentech, a member of the Roche Group, announced that pivotal data from the Phase III HAVEN 3 study, which evaluated HEMLIBRA prophylaxis administered every week or every two weeks in adults and adolescents aged 12 years or older with hemophilia A without factor VIII inhibitors, were published in the August 30, 2018, issue of the New England Journal of Medicine. “In the HAVEN 3 study, HEMLIBRA showed a significant and clinically meaningful reduction in bleeds in people with hemophilia A without factor VIII inhibitors, while offering multiple subcutaneous dosing options,” said Dr. Johnny Mahlangu, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, South Africa. “The publication of these results in the New England Journal of Medicine represents a major advance for hemophilia research and reinforces the potential of HEMLIBRA to change the standard of care for people with hemophilia A.” The Phase III HAVEN 3 study in people with hemophilia A without factor VIII inhibitors met its primary endpoint and key secondary endpoints. Earlier this year, the FDA granted Breakthrough Therapy Designation and Priority Review to HEMLIBRA for people with hemophilia A without factor VIII inhibitors based on data from the HAVEN 3 study. The FDA is expected to make a decision on approval by October 4, 2018. https://thefly.com/landingPageNews.php?id=2783729