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Roche reports positive interim results for emicizumab in phase III HAVEN 2 study of children with haemophilia A

Basel, Switzerland
Tuesday, April 18, 2017, 09:00 Hrs  [IST]

Roche has announced interim results from the phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with haemophilia A and inhibitors to factor VIII. At this interim analysis after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful reduction in the number of bleeds over time.

These findings are consistent with results from the phase III HAVEN 1 study in adults and adolescents (12 years of age or older) with haemophilia A and inhibitors to factor VIII, in which emicizumab prophylaxis showed a statistically significant and clinically meaningful reduction in the number of bleeds over time compared to no prophylaxis, as well as compared to prior prophylaxis with bypassing agents. The most common adverse events with emicizumab in the HAVEN2 study were injection site reactions and nasopharyngitis.

“Managing haemophilia A with inhibitors to factor VIII is especially challenging for children and their caregivers, because bleeding is difficult to control and current treatments require frequent intravenous infusions”, said Sandra Horning, MD, chief medical officer and head of global product development.

“We are encouraged that once-weekly subcutaneous emicizumab prophylaxis showed a clinically meaningful reduction in the number of bleeds over time in children and are pleased to share these results with the community as we join in celebrating World Hemophilia Day.”

HAVEN 2 is the second phase III study in the emicizumab clinical development programme to report results. Data from both HAVEN 1 and the interim data from HAVEN 2 studies will be presented at an upcoming medical meeting and submitted to health authorities for approval consideration.

The development programme for emicizumab reflects Roche’s commitment to help address clinical unmet needs in the treatment of haemophilia A. As part of this commitment, Roche and Genentech are proud to support the World Federation of Hemophilia and the global bleeding disorders community as sponsors of World Hemophilia Day.

HAVEN 2 is a single-arm, multicentre, open-label, phase III study evaluating the efficacy, safety, and pharmacokinetics of once weekly subcutaneous administration of emicizumab. The interim analysis after a median of 12 weeks of treatment included 19 children less than 12 years of age with haemophilia A and inhibitors to factor VIII, who require treatment with bypassing agents. The objectives of the study are to evaluate the number of bleeds over time with emicizumab prophylaxis, safety, pharmacokinetics, health-related quality of life (HRQoL) and proxy HRQoL with aspects of caregiver burden. The study will enrol a total of 60 children for its final analysis planned after 52 weeks of treatment with emicizumab.

 

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