Genentech Announces Interim Result from Phase III HAVEN 4 Study
Note: The following is an edited excerpt from a press release from Genentech. To read the press release in it’s entirety, click HERE.
Genentech, a member of the Roche Group, announced today positive interim results from the Phase III HAVEN 4 study evaluating HEMLIBRA® (emicizumab-kxwh) prophylaxis dosed once every four weeks in adults and adolescents (12 years of age or older) with hemophilia A with and without inhibitors to factor VIII. At this interim analysis after a median of 17 weeks of treatment, HEMLIBRA prophylaxis showed a clinically meaningful control of bleeding. These results are consistent with previous studies of HEMLIBRA dosed once weekly or every two weeks, including the pivotal studies in hemophilia A with inhibitors, HAVEN 1 in adults and adolescents and HAVEN 2 in children, as well as the Phase III HAVEN 3 study in adults and adolescents with hemophilia A without inhibitors. 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.
Assisting and Advocating for the Bleeding Disorders Community