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December 14, 2021updated 07 Jan 2022 7:06am

Roche’s Hemlibra shows bleed control in Phase III haemophilia trial

Interim data from the trial showed that 80.3% of patients had no bleeding episodes that needed treatment.

Roche has reported interim assessment data from the Phase III HAVEN 6 clinical trial where its Hemlibra (emicizumab) therapy showed effective control in bleeding in moderate or mild haemophilia A patients without factor VIII inhibitors.

A bispecific factor IXa-directed and factor X-directed antibody, Hemlibra was created by Chugai Pharmaceutical and is being jointly developed worldwide by the company, along with Roche and Genentech.

Intended to be administered subcutaneously as prophylactic (preventative) therapy, it can potentially reinstate the blood clotting process in haemophilia A patients.

The Phase III trial is assessing the safety, efficacy, pharmacodynamics and pharmacokinetics of Hemlibra in moderate or mild haemophilia A patients without factor VIII inhibitors.

According to the interim analysis results from 71 subjects, Hemlibra was found to have an encouraging safety profile and efficient bleeding control.

Findings showed that 80.3% of subjects had no bleeding episodes that need treatment while 90.1% reported no joint bleeds that needed therapeutic intervention.

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Annualised bleeding rates (ABR) were found to be low and in line with data reported earlier in the HAVEN 1 to HAVEN 4 trials.

In the trial, headache and local injection site reactions were observed to be the most common adverse events (AEs).

No cases of death or thrombotic microangiopathy or major thrombotic events were reported in the trial so far, supporting the favourable safety profile of Hemlibra.

Roche Global Product Development head and chief medical officer Levi Garraway said: “We are pleased to see that Hemlibra continues to show benefit in additional haemophilia A populations, regardless of severity.

“The clinical evidence for Hemlibra derives from one of the largest pivotal clinical trial programmes in haemophilia A, with and without factor VIII inhibitors.”

This July, the company reported data from the final analysis of the Phase IIIb STASEY trial, establishing the favourable safety profile of Hemlibra for haemophilia A treatment.

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