New follow-up phase III data reinforce the long-term benefit of Roche ’s Hemlibra for people with haemophilia A

Basel, 7 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced results from a new analysis of pooled, three-year follow-up data of 401 people with haemophilia A from the pivotal HAVEN 1-4 studies, which reinforce the long-term efficacy and safety profile of Hemlibra ® (emicizumab).[1]These data, from adults, adolescents and children with haemophilia A with and without factor VIII inhibitors, were presented at the all-virtual 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 5-8 December 2020.“The long-term benefit of Hemlibra, with a consistent safety profile and durably effective control of bleeding, underscores its potential to redefine the standard of care for people living with haemophilia A,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Pr oduct Development. “As the first new class of medicine in nearly 20 years, Hemlibra continues to show a positive impact on disease burden and quality of life for people with haemophilia A, regardless of their inhibitor status or age.” The analysis included pooled data from 401 people with haemophilia A with and without factor VIII inhibitors, from across the four pivotal HAVEN studies  (HAVEN 1, n=113; HAVEN 2, n=88; HAVEN 3, n=152; HAVEN 4, n=48) with a median duration efficacy period of 120.4 weeks.[1]Hemlibra maintained low treated bleed rates across the study period, with model based annualised bleed rates (ABR) remaining...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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Source: Critical Care Medicine - Category: Emergency Medicine Tags: Online Clinical Investigations Source Type: research
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Source: Critical Care Medicine - Category: Emergency Medicine Tags: Online Review Article Source Type: research
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Source: Critical Care Medicine - Category: Emergency Medicine Tags: Clinical investigations Source Type: research
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Source: Critical Care Medicine - Category: Emergency Medicine Tags: Neurologic Critical Care Source Type: research
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