Roche Media Release: Positive phase III results for Roche’s emicizumab in haemophilia A published in The New England Journal of Medicine Montag, 10. Juli 2017 - 11:30
Positive phase III results for Roche's emicizumab in haemophilia A published in The New England Journal of Medicine | |
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| HAVEN 1 showed emicizumab reduced bleed rate by 87% compared with on-demand bypassing agents |
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| All 12 secondary endpoints in HAVEN 1 were positive, including an intra-patient comparison that showed emicizumab reduced bleed rate by 79% compared to prior prophylactic bypassing agents |
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| Data from HAVEN 1 in adults and adolescents and interim data from HAVEN 2 in children with haemophilia A with inhibitors are being presented today at the 26th International Society on Thrombosis and Haemostasis (ISTH) Congress |
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| Data from both studies have been submitted to FDA and EMA for approval consideration |
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Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data from HAVEN 1, a phase III study evaluating once-weekly subcutaneous emicizumab prophylaxis (preventative) in adults and adolescents with haemophilia A with inhibitors, were published in The New England Journal of Medicine (NEJM). The primary endpoint showed a clinically meaningful and statistically significant reduction in treated bleeds of 87% (risk rate [RR]=0.13, p
“Nearly one in three people with haemophilia A develop inhibitors to standard factor VIII therapy, leaving them at greater risk of life-threatening bleeds and long-term joint damage,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Based on the bleed reduction shown in the HAVEN 1 and HAVEN 2 studies, we believe emicizumab has the potential to make a meaningful difference for people with haemophilia A with inhibitors, while also reducing the burden of managing the condition with a subcutaneous, once-weekly administration.”
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