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Home Industry News Roche’s emicizumab shows strong performance in haemophilia A trial

Roche’s emicizumab shows strong performance in haemophilia A trial

23rd December 2016

Roche has announced the results of a phase III clinical trial showing the strong performance of emicizumab in the treatment of haemophilia A.

The phase III HAVEN 1 study was conducted to evaluate emicizumab prophylaxis in patients aged 12 years or older with haemophilia A and inhibitors to factor VIII. Results showed that the drug was able to meet its primary endpoint.

A statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis was seen compared to those receiving no prophylactic treatment, while all secondary endpoints of the study were also met.

HAVEN 1 is the first phase III study in a wider emicizumab clinical development programme to deliver results. Data from this study will be presented at an upcoming medical meeting and submitted to health authorities around the world to support applications for marketing authorisation.

Dr Sandra Horning, chief medical officer and head of global product development at Roche, said: "We are pleased to see that, in our first pivotal trial, emicizumab prophylaxis significantly reduced the number of bleeds over time in people in this difficult-to-treat setting."

Emicizumab was originally created by Chugai Pharmaceutical and is now being co-developed as a collaboration between Chugai, Roche and Genentech.

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