Business Wire

Chugai's Bispecific Antibody "Emicizumab" Global Phase III Data in Patients with Haemophilia A with Inhibitors Published in The New England Journal of Medicine Online

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the data from HAVEN 1 study (NCT02622321) was published in the online version of The New England Journal of Medicine (NEJM). This global phase III study examined Chugai’s bispecific antibody emicizumab in adults and adolescents 12 years of age or older with haemophilia A with inhibitors. Results of HAVEN 1 study and the interim analysis of HAVEN 2 study (NCT02795767), a global phase III study of emicizumab in paediatric patients with haemophilia A with inhibitors, are presented today at the 26th International Society on Thrombosis and Haemostasis (ISTH) Meeting in Berlin.

“HAVEN 1 study is the first global phase III study for emicizumab. This important data provides the body of evidence for the upcoming new drug application,” said Chugai’s President & COO, Tatsuro Kosaka. “The interim analysis of HAVEN 2 study showed that emicizumab offers benefit for children as well. Chugai is committed to provide a new treatment option as soon as possible for the disease which may severely affect patients' life.”

Chugai is currently preparing to file the new drug application in Japan for emicizumab based on the data of HAVEN 1 study and the interim analysis of HAVEN 2 study. These data have been filed with the US Food and Drug Administration (FDA) and the European Medicines Agency by Roche. Emicizumab was designated as a Breakthrough Therapy by the FDA for the prophylactic treatment of people who are 12 years or older with haemophilia A with factor VIII inhibitor in September 2015.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Koki Harada
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
***
For US media
Chugai Pharma USA Inc.
Casey Astringer
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com
***
For European media
Chugai Pharma France SAS
Nathalie Leroy
Tel: +33-1-56-37-05-21
E-mail: pr@chugai.eu
***
For Taiwanese media
Chugai Pharma Taiwan Ltd.
Susan Chou, Osamu Kagawa
Tel: +886-2-2715-2000
E-mail: pr@chugai.com.tw
***
For Investors
Chugai Pharmaceutical Co., Ltd.
Investor Relations Group, Corporate Communications Dept.,
Toshiya Sasai
Tel: +81-3-3273-0554
E-mail: ir@chugai-pharm.co.jp

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Synteract Announces Collaboration with International Children’s Advisory Network iCAN Research25.6.2018 20:03Tiedote

Synteract, an innovative contract research organization (CRO) providing full, phase I-IV services enabling drug development companies to bring new medicines to market, has signed a memo of understanding to partner with the International Children’s Advisory Network (iCAN). A worldwide consortium of children’s advisory groups, iCAN is dedicated to giving children and families a voice in health, medicine, research, and innovation by increasing education about the importance of children’s involvement. Synteract is a sponsor at the 2018 iCAN Research Summit in Edinburgh, Scotland, UK, July 8-13, 2018 and will hold two interactive plenary seminar sessions at the event. With chapters across the U.S. and worldwide, iCAN partners with local children’s hospitals and addresses the needs of pediatric clinical research and healthcare and advocates for patients worldwide. In partnering with iCAN, Synteract will expand its access to children and families familiar with clinical research. iCAN will sup

GA-ASI to Fly First Trans-Atlantic Flight of a MALE RPA25.6.2018 19:55Tiedote

On July 10-11, General Atomics Aeronautical Systems, Inc. (GA-ASI) plans to make the first-ever trans-Atlantic flight of a Medium-altitude, Long-endurance (MALE) Remotely Piloted Aircraft (RPA). GA-ASI’s company-owned MQ-9B SkyGuardian RPA is scheduled to fly from the company’s Flight Test and Training Center in Grand Forks, North Dakota, USA, to Royal Air Force (RAF) Fairford in Gloucestershire, UK. The aircraft will then be on static display July 13-15 for the Royal International Air Tattoo (RIAT) airshow being held at RAF Fairford. The flight and display will commemorate the RAF’s centenary celebration (RAF100). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180625005946/en/ GA-ASI’s company-owned MQ-9B SkyGuardian RPA is scheduled to fly from the company’s Flight Test and Training Center in Grand Forks, North Dakota, USA, to Royal Air Force (RAF) Fairford in Gloucestershire, UK. The aircraft will then be on static displa

Quadient Announces General Availability of Quadient Inspire R1225.6.2018 17:30Tiedote

www.quadient.com : Quadient, the award-winning leader in Customer Communications Management (CCM), announced the general availability of its newest release, Quadient Inspire R12, which includes the new Digital Advantage Suite. The updated version of Quadient Inspire is designed to give customers and partners greater control over the systems and processes used to drive consistent communications across all channels with an emphasis on digital experiences. With Inspire R12, users design omni-channel communications in days rather than months with a simple, modern and comprehensive platform. The solution makes it possible to change designs and test for all channels in minutes, with fully integrated tracking and approval processes built in. Additionally, R12 integrates all parts of the communications process from linking journey maps to communications, postal sorting, address, phone and email verifications, email delivery, SMS delivery, mail delivery tracking, and production monitoring to re

The Dementia Discovery Fund Raises $350 Million25.6.2018 16:00Tiedote

The Dementia Discovery Fund (DDF) today announces the completion of its fundraising, with £250 million ($350 million at the time of completion) raised from an influential group of strategic investors committed to developing new medicines for dementia. The goal was met today with a new investment of $60 million from US AARP, the global nonpartisan organisation dedicated to empowering Americans 50 and older to choose how they live as they age. The fundraising far exceeded its initial target of $200 million (£130 million), making it the first and largest venture fund focused entirely on discovering and developing novel therapies for dementia, including Alzheimer’s disease. The DDF makes early stage venture capital investments to develop novel disease-modifying therapeutics for all forms of dementia. The fund is managed by SV Health and was formed through the collaboration of leading pharmaceutical companies (Biogen, Eli Lilly and Company, GSK, Johnson & Johnson, Otsuka (Astex), Pfizer and

Professor Thierry Philip Takes Office as OECI President25.6.2018 15:22Tiedote

Professor Thierry Philip, President of the Institut Curie, has been elected President of the Organisation of European Cancer Institutes ( OECI ) for a three-year term. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180625005600/en/ Pr Thierry Philip (Photo: Business Wire) At the end of June 2018, Professor Philip, an oncologist and pediatrician, will take over as head of this European organization, which brings together 90 institutes and university centers and whose mission is fully devoted to cancer. This European non-governmental, non-profit organization aims to promote cooperation between its members or associate members and pursues a triple objective: to provide cancer patients in Europe with equal access to high-quality care; to assist European institutes with the implementation of a quality system for oncology care; to promote and accelerate the progress of translational research. In this regard, half of the 90 OECI ce

Boehringer Ingelheim and Lilly announce positive top-line Phase III data results for empagliflozin as adjunct to insulin in type 1 diabetes25.6.2018 15:07Tiedote

Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced that both randomised controlled trials in the EASE phase III programme, investigating the use of empagliflozin in combination with insulin therapy in adults with type 1 diabetes, met their primary endpoint. The primary efficacy endpoint, defined in both trials as placebo-corrected change from baseline in HbA1c after 26 weeks of treatment, was met for all investigated doses of empagliflozin (2.5, 10, and 25 mg). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180625005579/en/ Type 1 diabetes currently affects approximately 30 million adults worldwide.1 It is an autoimmune disease in which the body does not produce sufficient amounts of insulin and therefore requires life-long daily insulin administration to regulate blood sugar. For some people with type 1 diabetes, it may be challenging to manage blood sugar levels with insulin alone. People with type

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme