New data reinforce favorable profile of Roche's Hemlibra in hemophilia A

Swiss pharma giant Roche (ROG: SIX) today announced results from the primary analysis of the Phase III HAVEN 6 study, which show that Hemlibra (emicizumab) continued to demonstrate a favorable safety profile and effective bleed control in people with moderate or mild hemophilia A, without factor VIII inhibitors.

The data will be presented at the 30th International Society on Thrombosis and Hemostasis (ISTH) Annual Congress, in London, UK, and are planned to support a submission to the European Medicines Agency to update the label for Hemlibra to include non-severe hemophilia A patients.

“We are proud that Hemlibra continues to redefine the standard of care for more people living with hemophilia A,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “The data presented at ISTH this year underscore Roche’s commitment to addressing gaps in care for haemophilia A, thereby ensuring that broader populations can potentially benefit from Hemlibra,” he noted.

In addition to HAVEN 6, data from the CHESS II (Cost of Hemophilia across Europe: a Socioeconomic Survey-II) and CHESS PAEDs studies will also be presented at ISTH 2022. These data show most adults with moderate or mild hemophilia A and more than half of children with moderate hemophilia A may not receive preventative treatments. This can result in worsened clinical burden, as more than 30% of adults and approximately 40% of Savechildren with moderate hemophilia A who were not taking preventative treatment in the study experienced at least three bleeds a year.

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