Roche's Genentech announces FDA approval of Hemlibra for Hemophilia A
Genentech, a member of the Roche Group, announced that the U.S. FDA has approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A without factor VIII inhibitors. Hemlibra is now the only prophylactic treatment for people with hemophilia A with and without factor VIII inhibitors that can be administered subcutaneously and at multiple dosing options. This approval is based on positive results from the Phase III HAVEN 3 and HAVEN 4 studies. Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis and across all other bleed-related endpoints in the HAVEN 3 study, and showed a clinically meaningful control of bleeding in the HAVEN 4 study. Hemlibra is now available to people in the U.S. who have hemophilia A without factor VIII inhibitors.