Roche has reported interim results from the phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with haemophilia A and inhibitors to factor VIII.
The company said in its press relesase issued on World hemophilia day that at this interim analysis, after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful reduction in the number of bleeds over time.
Furthermore, the company said that these findings are consistent with results from the phase III HAVEN 1 study in adults and adolescents (12 years of age or older) with haemophilia A and inhibitors to factor VIII, in which emicizumab prophylaxis showed a statistically significant and clinically meaningful reduction in the number of bleeds over time compared to no prophylaxis, as well as compared to prior prophylaxis with bypassing agents. The most common adverse events with emicizumab in the HAVEN2 study were injection site reactions and nasopharyngitis.
“Managing haemophilia A with inhibitors to factor VIII is especially challenging for children and their caregivers, because bleeding is difficult to control and current treatments require frequent intravenous infusions”, said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.
In addition, the company announced, phase III studies of emicizumab are ongoing:
HAVEN 3, evaluating emicizumab prophylaxis dosed once weekly or once every other week in people 12 years of age or older with haemophilia A without inhibitors to factor VIII.
HAVEN 4, evaluating emicizumab prophylaxis dosed every four weeks in people 12 years of age or older with haemophilia A with or without inhibitors to factor VIII.