Roche's Phase III Hemlibra Data Reinforce Safety Profile In People With Haemophilia A

Roche (RHHBY) said that final analysis from phase IIIb STASEY study, including data from 193 people with haemophilia A, further supported the benefit/risk profile of Hemlibra or emicizumab. The study results consistent with the phase III HAVEN clinical program.

In the analysis, no new safety signals were identified with longer-term Hemlibra treatment in adults and adolescents with haemophilia A with inhibitors to factor VIII, the clotting protein that is missing or defective in people with haemophilia A.

The data were presented at the virtual International Society on Thrombosis and Haemostasis 2021 Congress, 17-21 July 2021.

The analysis did not show any new cases of thrombotic microangiopathy or serious thrombotic events related to Hemlibra. The most common adverse events occurring in 10% or more of people in the STASEY study were joint pain, common cold symptoms , headache, injection site reaction and fever.

The company noted that Hemlibra also continued to demonstrate effective bleed control in the STASEY study, with 82.6% of participants experiencing no bleeding episodes that required treatment. Annualised bleeding rates were consistent with previously reported observations from the pivotal HAVEN studies.

Hemlibra has been approved in more than 100 countries worldwide for the treatment of people with haemophilia A with factor VIII inhibitors.

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