Roche unveils wave of strong Hemlibra data in haemophilia A with or without factor VIII inhibitors

pharmafile | July 9, 2019 | News story | Manufacturing and Production, Research and Development Roche, haemophilia, pharma 

Roche revealed a swathe of new data on Hemlibra (emicizumab) at the International Society on Thrombosis and Haemostasis (ISTH) 2019 Congress, reinforcing the bispecific factor IXa- and factor X-directed antibody’s efficacy and safety in the treatment of haemophilia A in patients with or without factor VIII inhibitors.

The presented data was pooled from four separate HAVEN studies, drawn from participants of all ages with and without factor VIII inhibitors over a median of 83 weeks. These data illustrated that 87% of all participants experienced no treated joint bleeds, either due to injury or spontaneous, while 92% suffered no spontaneous bleeds in each interval from week 25.

Furthermore, two of the HAVEN studies demonstrated Hemlibra as a prophylaxis provided a “clinically meaningful improvement in long-term health-related quality of life” compared to previous episodic or preventative factor VIII treatment, as measured on the Haem-A-QoL questionnaire. After 25 weeks of treatment, 91% and 93% of patients in each of the two trials reported now missed workdays, compared to 76% and 79% in the 28 days prior to the beginning of the trials.

In addition, results from the Phase 3b STASEY trial revealed that none of its 88 participants experienced anythrombotic microangiopathy or thrombotic events, and the therapy’s safety profile was found to be consistent with previous studies.

“Data presented at ISTH continues to reinforce Hemlibra’s potential to redefine the standard of care for people living with haemophilia A,” remarked Dr Sandra Horning, 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.”

Matt Fellows

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