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Roche Presents Positive Hemlibra Data Across Multiple Pivotal Studies

Swiss drug major Roche Group (RHHBY) announced Tuesday new data for Hemlibra (emicizumab) across multiple pivotal studies, demonstrating continued benefits for people with haemophilia A.

The data was presented at the International Society on Thrombosis and Haemostasis or ISTH 2019 Congress on 6-10 July in Melbourne, Australia.

Sandra Horning, Roche's Chief Medical Officer and Head of Global Product Development, said, "Data presented at ISTH continues to reinforce Hemlibra's potential to redefine the standard of care for people living with haemophilia A. 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."

Roche presented 21 abstracts in total from its haemophilia programme, including five oral presentations. The company presented further data from the four pivotal HAVEN clinical trials that demonstrated the long-term safety, efficacy and quality of life benefit of Hemlibra in people with haemophilia A with and without factor VIII inhibitors.

In addition, the company presented the first interim analysis from the phase IIIb STASEY study. This study reinforced the safety profile of Hemlibra in adults and adolescents with haemophilia A with factor VIII inhibitors seen in the HAVEN 1 clinical trial.

At present, Hemlibra is approved for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people with haemophilia A with factor VIII inhibitors in over 70 countries. It has also been approved in people with haemophilia A without factor VIII inhibitors in over 40 countries.

Submissions to other regulatory authorities around the world are ongoing.

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