Health Canada approves Hemlibra for haemophilia A patients without factor VIII inhibitors

Roche

18 June 2019 - Hemlibra is the only treatment that can be self-injected subcutaneously once weekly for patients with hemophilia A without factor VIII inhibitors.

Roche announced today that Health Canada has approved Hemlibra (emicizumab injection) for haemophilia A (congenital factor VIII deficiency) patients without factor VIII inhibitors as routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes. Limited data exists for patients suffering from mild and moderate haemophilia A. The announcement follows last year's approval of Hemlibra for haemophilia A patients with factor VIII inhibitors.

The efficacy and safety of Hemlibra has been demonstrated by one of the largest clinical trial programmes ever conducted in hemophilia A patients, with and without factor VIII inhibitors, in four pivotal HAVEN studies (HAVEN 1, HAVEN 2, HAVEN 3, HAVEN 4).

Read Roche press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Outcome , Medicine , Canada