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.