Roche ’s Hemlibra significantly reduced bleeds in phase III study in haemophilia A

Roche today announced positive results from the phase III HAVEN 3 study evaluating Hemlibra ® (emicizumab) in adults and adolescents (aged 12 years or older) with haemophilia 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 prophylaxi s. Importantly, once-weekly Hemlibra prophylaxis was superior to factor VIII prophylaxis, as demonstrated by a statistically significant and clinically meaningful reduction in treated bleeds in an intra-patient comparison of patients receiving Hemlibra prophylaxis compared to their prior factor VIII 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.
Source: Roche Media News - Category: Pharmaceuticals Source Type: news