Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth

The HAVEN 7 studywas designed to further confirm the benefit of preventative treatment (prophylaxis) withHemlibra from birth in previously untreated or minimally treated infants with severehaemophilia A without inhibitorsIn the study, 77.8% of participants had no bleeding episodes that required treatment1In addition, real-world efficacy and safety data from the EUHASS database and ATHN 7 study were also presented2,3Basel, 11 December 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced interim results from the phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab) achieved meaningful bleed control with a favourable safety profile in infants (up to 12 months) with severe haemophilia A, without factor VIII inhibitors: 77.8% of participants did not have any bleeds that required treatment and 42.6% did not have any treated or untreated bleeds at all.1 These results help support the use of Hemlibra in this population,  in which it is already approved in many countries around the world. The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from 10-13 December 2022.The burden of severe haemophilia A in infants and on their parents and caregivers is significant. The World Federation of Haemophilia treatment guidelines consider the standard of care in haemophilia to be regular prophylaxis initiated at a young age, as studies have shown that early prophylaxis improves long-term outcomes,...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news