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Genentech's Hemlibra provided sustained bleed control in pivotal study.

Genentech, a member of the Roche Group, announced data from the primary analysis of the Phase III HAVEN 2 study evaluating Hemlibra prophylaxis in children younger than 12 years of age with hemophilia A with factor VIII inhibitors, including longer follow-up for once-weekly dosing and new data for less frequent dosing schedules. These data from the largest pivotal study in children with hemophilia A with factor VIII inhibitors were presented at the 60th American Society of Hematology Annual Meeting. In updated results from the HAVEN 2 study with a median of 11 additional months of data, 76.9 percent of children with hemophilia A with factor VIII inhibitors treated with Hemlibra once weeklyexperienced zero treated bleeds. Importantly, once-weekly Hemlibra showed a 99 percent reduction in treated bleeds compared to prior treatment with bypassing agents as prophylaxis or on-demand in a prospective intra-patient comparison. New data also showed that 90 percent of children with factor VIII inhibitors receiving Hemlibra every two weeks and 60 percent of children receiving Hemlibra every four weeks experienced zero treated bleeds, demonstrating clinically meaningful bleed control at both dosing schedules. No cases of thrombotic microangiopathy or thrombotic events occurred. The most common adverse events in the HAVEN 2 study primary analysis were consistent with those previously observed in the interim analyses. Hemlibra is approved in over 50 countries worldwide, including the U.S., EU member states and Japan, to treat people of all ages with hemophilia A with factor VIII inhibitors based on pivotal data that included interim results from the HAVEN 2 study.

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Publication:The Fly
Date:Dec 3, 2018
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