- New analyses from phase III HAVEN studies support Hemlibra’s sustained efficacy, safety and quality of life benefit in people with haemophilia A, with and without factor VIII inhibitors
- First data of phase IIIb STASEY study reinforces safety profile of Hemlibra seen in pivotal HAVEN 1 clinical trial
- New analysis of pivotal data suggests additional factor treatment may not be needed for people on Hemlibra undergoing certain minor surgery
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data for Hemlibra® (emicizumab) across multiple pivotal studies in people with haemophilia A with and without factor VIII inhibitors at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress on 6-10 July in Melbourne, Australia. In total, Roche presented 21 abstracts from its haemophilia programme, including five oral presentations. Further data from the four pivotal HAVEN clinical trials were presented, demonstrating the long-term safety, efficacy and quality of life benefit of Hemlibra in people with haemophilia A with and without factor VIII inhibitors. Roche also presented the first interim analysis from the phase IIIb STASEY study, reinforcing the safety profile of Hemlibra in adults and adolescents (aged 12 years or older) with haemophilia A with factor VIII inhibitors seen in the HAVEN 1 clinical trial.
“Data presented at ISTH continues to reinforce Hemlibra’s potential to redefine the standard of care for people living with haemophilia A,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are particularly excited to present the first interim analysis of safety data from the STASEY study, which adds to the growing body of evidence supporting Hemlibra as an important treatment option for people with haemophilia A.”
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