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Genentech: Phase IIIb Study Data Reinforces Safety Profile Of Hemlibra In Hemophilia A Patients

Genentech, a member of the Roche Group (RHHBY), announced Monday that the second interim analysis of the Phase IIIb STASEY study reinforced the safety profile of Hemlibra (emicizumab-kxwh) in people with Hemophilia A.

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for hemophilia A patients.

STASEY is a single-arm, multicenter, open-label, Phase IIIb clinical study where patients received Hemlibra for an average of 50.9 weeks.

In the STASEY study, Hemlibra was effective with no new safety signals identified in adults and adolescents with hemophilia A with factor VIII inhibitors, which was consistent with previous safety observations. Further new interim data suggest that people on Hemlibra may be able to undergo certain minor surgeries without additional preventative (prophylactic) coagulation factor.

The safety profile of Hemlibra were characterized in the Phase III HAVEN clinical program. Annualized bleeding rates or ABR were also consistent with previously reported observations from the HAVEN studies.

Hemlibra is approved to treat people with hemophilia A with factor VIII inhibitors in more than 90 countries worldwide and for people without factor VIII inhibitors in more than 70 countries worldwide, including the U.S., EU and Japan.

The company presented these data at the International Society on Thrombosis and Haemostasis or ISTH 2020 Virtual Congress, July 12-14, 2020.

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