Chugai Publishes Results of Phase 3 Study on Hemophilia A Med

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) today announced that results of the HAVEN 3 study (NCT02847637), the global phase III study evaluating hemophilia A treatment, HEMLIBRA^® (generic name: emicizumab [genetical recombination]), were published in the 30 August 2018 issue of the New England Journal of Medicine (NEJM).
Article: https://www.nejm.org/doi/full/10.1056/NEJMoa1803550
Quick video summary by NEJM: https://www.nejm.org/do/10.1056/NEJMdo005333/full/

The study evaluated the efficacy and safety of HEMLIBRA subcutaneous injection, once a week and once every two weeks, in people with hemophilia A (12 years of age or older) without inhibitors to factor VIII. Detailed results of the study were presented at the World Federation of Hemophilia (WFH) 2018 World Congress held in Glasgow, Scotland on May 21, 2018.

“This is the third time that the clinical data of HEMLIBRA have been published in NEJM, following the results of the phase I/II studies and the first phase III study. It demonstrates a high medical value that the drug may bring to the treatment of hemophilia A,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “We are committed to deliver HEMLIBRA which has been created with our proprietary bispecific antibody technologies, as a new treatment option to people with hemophilia A without inhibitors as early as possible in cooperation with Roche.”

In May 2018, HEMLIBRA was launched in Japan for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with congenital factor VIII deficiency (hemophilia A) with factor VIII inhibitors. An application for an additional indication of the treatment of hemophilia A without factor VIII inhibitors has been filed in April in Japan. Applications for the same additional indication have also been filed in the United States and Europe. In the U.S., the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation in April, and Priority Review in June, for this line extension. In Europe, the review by the EU Committee for Medicinal Products for Human Use (CHMP) is ongoing.

https://bit.ly/2MBnuwy