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Genentech: HEMLIBRA Reduces Treated Bleeds In HAVEN 3 Study

Genentech, a member of the Roche Group (RHHBY), announced Monday that HEMLIBRA (emicizumab-kxwh) reduced treated bleeds by 96 percent compared to no prophylaxis in phase III HAVEN 3 study in hemophilia A without factor VIII inhibitors.

The company announced full results from the Phase III HAVEN 3 study evaluating HEMLIBRA prophylaxis administered every week or every two weeks in people with hemophilia A without factor VIII inhibitors and the Phase III HAVEN 4 study evaluating HEMLIBRA prophylaxis administered every four weeks in people with hemophilia A with or without factor VIII inhibitors.

Data from both pivotal studies were presented as late-breaking abstracts at the World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, Scotland.

Johnny Mahlangu, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, South Africa, said, "HEMLIBRA is the first medicine to show superior efficacy to prior factor VIII prophylaxis, the current standard of care therapy, as demonstrated by a statistically significant reduction in treated bleeds in the HAVEN 3 study intra-patient comparison. Even with current prophylactic treatments, many people with hemophilia A continue to have bleeds that can lead to long-term joint damage, and there is a need for more treatment options."

In April 2018, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to HEMLIBRA for people with hemophilia A without factor VIII inhibitors, based on data from the HAVEN 3 study.

HEMLIBRA was approved by the FDA in November 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors based on results from the HAVEN 1 study and interim results from the HAVEN 2 study.

HEMLIBRA was also recently approved by regulatory authorities in other countries around the world, including by the European Commission in February 2018 for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.

Data from both the HAVEN 3 and HAVEN 4 studies are being submitted to health authorities around the world for approval consideration.

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