Phase III HAVEN 4 trial of Hemlibra positive for prophylaxis of hemophilia A patients dosed once every four weeks. Roche/Genentech.

Genentech, a member of the Roche Group announced 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. Data from the HAVEN 4 study will be presented at an upcoming medical meeting and submitted to health authorities around the world for approval consideration. These results add to the growing body of evidence supporting that Hemlibra may benefit all people with hemophilia A regardless of inhibitor status, while providing flexible and less burdensome administration options.