BRIEF—Roche broadens label for Hemlibra in Europe

Swiss cancer giant Roche has successfully expanded the approved indications for Hemlibra (emicizumab) in Europe for people with hemophilia A.

The label now includes routine prophylaxis of bleeding episodes in people with moderate disease, with a severe bleeding phenotype, who do not have factor VIII inhibitors.

This approval is based on the results of the Phase III HAVEN 6 study.

Hemlibra  first gained US Food and Drug Administration approval for people with hemophilia A, without factor VIII inhibitors, in 2018.

Chief medical officer Levi Garraway said: “As its benefit expands to broader populations, we remain committed to determining how Hemlibra might help even more people with hemophilia A to live a bleed-free life.”