January 2018—Genentech announced the FDA’s approval of Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. Nearly one in three people with severe hemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk for life-threatening bleeds or repeated bleeds that can cause long-term joint damage. In two of the largest pivotal clinical studies for people with hemophilia A with inhibitors (HAVEN 1 and HAVEN 2), Hemlibra was shown to substantially reduce bleeds in adults and children.
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