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Japan : Chugais Bispecific Antibody Emicizumab Meets Primary Endpoint in Phase III Study - emicizumab prophylaxis shown to reduce bleeding in patients without inhibitors.

Chugai Pharmaceutical Co., Ltd announced today that the primary endpoint has been met for the global phase III HAVEN 3 (NCT02847637) study evaluating emicizumab (ACE910) subcutaneous injection, once a week and once every two weeks, in patients with hemophilia A (12 years of age or older) without inhibitors to factor VIII. A statistically significant reduction in the number of bleeds was confirmed in patients treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. The study also met a secondary endpoint that once-weekly emicizumab prophylaxis was superior to factor VIII prophylaxis, as demonstrated by a statistically significant and clinically meaningful reduction in treated bleeds in an intra-patient comparison of patients receiving emicizumab prophylaxis compared to their prior factor VIII prophylaxis. The most common adverse events with emicizumab were injection site reactions, consistent with prior studies. No thrombotic events occurred in this study. Further details will be presented at a future medical meeting.

Prophylactic factor VIII replacement therapy is a standard treatment for hemophilia A patients without inhibitors. However, some patients and their caregivers have difficulties with the frequent intravenous injections in their daily life, said Chugais Senior Vice President, Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. As a subcutaneous injection, emicizumab can be administered more easily. Todays results, which are consistent with data reported from patients with inhibitors earlier this year, showed that emicizumab may have the potential to become an efficacious treatment option for hemophilia A patients without inhibitors. We expect emicizumab to provide benefits to a wide range of patients with hemophilia A.

Emicizumab is an investigational bispecific monoclonal antibody, which was developed using Chugais proprietary antibody engineering technologies. The drug is designed to bind factor IXa and factor X. In doing so, emicizumab provides the cofactor function of factor VIII in people with hemophilia A, who either lack or have impaired coagulation function of factor VIII1,2). In November this year, the drug (US product name: HEMLIBRA; Genentech) was approved by the U.S. Food and Drug Administration for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors. An EU marketing authorization application was submitted in June 2017 and is being reviewed under Accelerated Assessment by the European Medicines Agency. In Japan, emicizumab obtained an orphan drug designation in August 2016 from the Ministry of Health, Labour and Welfare for the prevention and reduction of bleeding episodes in patients with congenital FVIII deficiency (hemophilia A) who developed inhibitors to FVIII, followed by an application for regulatory approval filed in July 2017.

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Publication:Mena Report
Date:Nov 20, 2017
Words:448
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