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November 21, 2017

Roche’s haemophilia A drug meets endpoints in Phase III trial

Roche has reported positive findings from the Phase III HAVEN 3 clinical trial of Hemlibra (emicizumab) conducted in adolescents and adults with haemophilia A without inhibitors to factor VIII.

Roche has reported positive findings from the Phase III HAVEN 3 clinical trial of Hemlibra (emicizumab) conducted in adolescents and adults with haemophilia A without inhibitors to factor VIII.

Hemlibra is a bispecific factor IXa and factor X-directed antibody being developed to combine the IXa and X proteins required to stimulate natural coagulation cascade and restore blood clotting process.

The trial met the primary endpoint of a statistically significant and clinically meaningful decrease in the number of treated bleeds over time with Hemlibra prophylaxis every week, compared to no prophylaxis.

A once-weekly prophylaxis of Hemlibra was found to be superior to previous factor VIII prophylaxis during an intra-patient comparison.

The randomised, multi-centre, open-label Phase III trial assessed the safety, efficacy and pharmacokinetics of subcutaneous 3mg/kg of Hemlibra prophylaxis in 152 subjects who had previously received factor VIII therapy.

“Hemlibra is the first product to show superior efficacy to factor VIII prophylaxis.”

Roche chief medical officer and Global Product Development head Sandra Horning said: “Hemlibra is the first product to show superior efficacy to factor VIII prophylaxis.

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“These results in people with haemophilia A without inhibitors represent the next step forward in our clinical trial programme, which includes the positive HAVEN 1 and interim HAVEN 2 data in people with inhibitors.”

The trial is also reported to have achieved key secondary endpoints such as significant and meaningful reduction in the number of treated bleeds over time in patients dosed with Hemlibra prophylaxis every two weeks.

With injection site reactions being the most common adverse events, the results did not show any new safety signals or thrombotic microangiopathy events.

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