Tuesday, June 2, 2026

New data from phase III HAVEN 6 study reinforce favourable


  • Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild haemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up [1]
  • New data also reinforce Hemlibra’s favourable safety profile, with no new safety signals observed [1]
  • There is limited information and treatment guidance on moderate and mild haemophilia A, which can lead to delayed or missed diagnoses of bleeding episodes [2]
  • Hemlibra is approved to treat people of all ages with haemophilia A with factor VIII inhibitors in more than 110 countries and for people of all ages without factor VIII inhibitors in more than 95 countries

Basel, 11 July 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from the primary analysis of the phase III HAVEN 6 study, which show that Hemlibra® (emicizumab) continued to demonstrate a favourable safety profile and effective bleed control in people with moderate or mild haemophilia A, without factor VIII inhibitors.[1] The data will be presented at the 30th International Society on Thrombosis and Haemostasis (ISTH) Annual Congress, on 11 July 2022, in London, United Kingdom, and are planned to support a submission to the European Medicines Agency to update the label for Hemlibra to include non-severe haemophilia A patients.

“We are proud that Hemlibra continues to redefine the standard of care for more people living with haemophilia A,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical…



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