Roche interim analysis of the phase III HAVEN 6 study, which show Hemlibra (emicizumab) demonstrated a favourable safety profile and effective bleed control in people with moderate or mild haemophilia A without factor VIII inhibitors.
The data were presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition as an oral presentation on 12 December 2021.
While the treatment and management of severe haemophilia A are well-established, there is less information and treatment guidance on moderate and mild haemophilia A, which can lead to delayed or missed diagnosis of bleeding episodes. Considering this population may not use preventative treatments, they may experience worsened clinical burden, with less than 30% of people with moderate or mild haemophilia A living a bleed-free life.
“We are pleased to see that Hemlibra continues to show benefit in additional haemophilia A populations, regardless of severity,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The clinical evidence for Hemlibra derives from one of the largest pivotal clinical trial programmes in haemophilia A, with and without factor VIII inhibitors. We remain committed to working together with the haemophilia community as we further explore the efficacy and safety of Hemlibra in broader populations.”
Haven 6
Haven 6 is a phase III study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of Hemlibra in people with moderate or mild haemophilia A without factor VIII inhibitors. This interim analysis included data from 71 participants (69 men and two women); 20 of whom had mild haemophilia A without factor VIII inhibitors and 51 had moderate haemophilia A without inhibitors. Thirty-seven participants were on factor VIII prophylaxis at baseline.