The following is an edited excerpt from a press release from Genentech. To read the press release in full, click here.
Genentech, a member of the Roche Group, announced positive results from the Phase III HAVEN 3 study evaluating HemlibraÂ (emicizumab-kxwh) in adults and adolescents (aged 12 years or older) with hemophilia A without inhibitors to factor VIII. The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in the number of treated bleeds over time in people receiving Hemlibra prophylaxis every week compared to those receiving no prophylaxis. The study also met key secondary endpoints, including a statistically significant and clinically meaningful reduction in the number of treated bleeds over time with Hemlibra prophylaxis dosed every two weeks compared to no prophylaxis. The most common adverse events with Hemlibra were injection site reactions, with no new safety signals observed. No thrombotic microangiopathy or thrombotic events occurred in this study.