Roche's Hemlibra every four weeks controlled bleeds in Phase III study
Roche announced interim results from the phase III HAVEN 4 study evaluating Hemlibra prophylaxis dosed once every four weeks in adults and adolescents with haemophilia 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 haemophilia 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 haemophilia 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 haemophilia A regardless of inhibitor status, while providing flexible and less burdensome administration options.