Business Wire

Chugai’s HEMLIBRA® Receives Priority Review Status from U.S. FDA for Hemophilia A Without Inhibitors

Jaa

Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that the U.S. Food and Drugs Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for HEMLIBRA® [US generic name: emicizumab-kxwh] for adults and children with hemophilia A without factor VIII inhibitors. The FDA is expected to make a decision on approval by 4 October, 2018. In the US, Genentech, Inc., a member of Roche Group is the BLA holder and is engaged in the development and distribution of HEMLIBRA, which was approved and launched for hemophilia A with inhibitors in November 2017.

“We are very proud that HEMLIBRA has been granted a second Priority Review for hemophilia A without inhibitors following the previous designation for hemophilia A with inhibitors, which underscores the innovation of this drug,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Yasushi Ito. “In treatment of hemophilia A without inhibitors, there still remain unmet medical needs in the management of bleeding. Given this Priority Review status, we hope to be able to contribute to people with hemophilia A and their caregivers as soon as possible by providing HEMLIBRA as a new treatment option that can be administered subcutaneously with good bleeding control and eased treatment burden.”

The sBLA filing and Priority Review are based on the results of HAVEN 3 study (NCT02847637), which has been conducted with adults and adolescents with hemophilia A without factor VIII inhibitors under a collaboration between Chugai, Roche and Genentech. In EU, Roche has already filed the results to the European Medicines Agency for a supplemental indication of hemophilia A without inhibitors.

Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in safety or effectiveness of the treatment, prevention or diagnosis of a serious disease. In Japan, HEMLIBRA received regulatory approval in March 2018 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 and, in April 2018, was filed to the Ministry of Health, Labour and Welfare for a supplemental indication of hemophilia A without inhibitors.

Trademarks used or mentioned in this release are protected by law.

About Chugai

Chugai Pharmaceutical is one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products. Chugai, based in Tokyo, specializes in prescription pharmaceuticals and is listed on the 1st section of the Tokyo Stock Exchange. As an important member of the Roche Group, Chugai is actively involved in R&D activities in Japan and abroad. Specifically, Chugai is working to develop innovative products which may satisfy the unmet medical needs, mainly focusing on the oncology area.

In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and laboratories in Ukima are conducting research for technology development for industrial production. Overseas, Chugai Pharmabody Research based in Singapore is engaged in research focusing on the generation of novel antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies. Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe.

The consolidated revenue in 2017 of Chugai totaled 534.2 billion yen and the operating income was 103.2 billion yen (IFRS Core basis).

Additional information is available on the internet at https://www.chugai-pharm.co.jp/english.

Contact information

For Media
Chugai Pharmaceutical Co., Ltd.
Media Relations Group, Corporate Communications Dept.,
Tomoko Shimizu
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
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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

REPLY Study on Artificial Intelligence: Quo vadis, AI?23.1.2019 13:00Tiedote

Artificial intelligence enable machines to better understand the surrounding context, giving them the ability to recognise sight, sound and speech. This is made possible by machine learning algorithms. A current study by Reply, conducted with the trend platform SONAR, shows which trends are still relevant in this area. The study highlights some aspects of the future potential of Artificial Intelligence (AI). Complex algorithms, Edge Computing tools that reduce latency periods and AI-specific hardware are yielding many new products and services for mobile computing, the Internet of Things (IoT) and Human-machine Interfaces. There are many different possible scenarios, and three trends play a major role in determining AI’s future as a game changer: AI-driven analytics In the era of digital transformation, decisions are made based on data with the help of predictive analytics. Companies in diverse industries use AI-as-a-service solutions from established providers or start-ups and increas

GSMA Announces Nominees for 2019 GLOMO Awards23.1.2019 12:00Tiedote

The GSMA today announced the nominees for the Global Mobile Awards 2019 (GLOMO Awards). Winners of the awards will be presented throughout MWC19 Barcelona, which takes place 25 - 28 February. The full list of nominees can be found at www.mwcbarcelona.com/conference-programmes/global-mobile-awards/global-mobile-awards-2019-nominee-shortlist/. “The GLOMOs provide a world stage on which to celebrate the most inspirational and innovative developments across our industry, recognising the companies and individuals leading the way in everything from 5G, to emerging markets, to intelligent connectivity,” said John Hoffman, CEO, GSMA Ltd. “The awards attract a significant level of high-quality entries, so being nominated today is a great achievement. We wish everyone the very best of luck and we look forward to some exciting announcements at MWC19 Barcelona.” The GLOMO Awards feature an afternoon ceremony at 16:30 CET on Tuesday, 26 February in Auditorium 5, Hall 4, and will include the present

Y Analytics Launches to Bring Together Capital and Research for Good23.1.2019 11:58Tiedote

Today marks the launch of Y Analytics, a new, independent organization established to drive increased and more effective investment in creating social and environmental good by equipping capital allocators with the research basis to effectively understand the impact of their decisions. The organization, headquartered in Washington, D.C. and led by Maryanne Hancock, will help bridge the divide between the research community and capital allocators. Ultimately, this will ensure that capital directed at addressing the United Nations Sustainable Development Goals is used most efficiently, and more broadly, that we advance our abilities to direct capitalism towards solutions that have the potential to create real, tangible impact. From Maryanne Hancock, CEO of Y Analytics: “We are building on the extensive effort of others, who have worked for decades to advance the world’s understanding of what creates impact. Y Analytics is built on the premise of learning from their work, utilizing resear

SpeeDx Increase European Distribution Network23.1.2019 11:00Tiedote

SpeeDx have announced signing two new distribution partners, creating comprehensive access for customers to market-leading SpeeDx ResistancePlus ® and PlexPCR ® tests across Europe. AB ANALITICA will distribute throughout Italy and Immuno Diagnostic Oy will cover Finland. “Our new distribution partners have strong sales presence in their regions and close working relationships with the key customers that are interested in our solutions,” says Colin Denver, SpeeDx CEO. “Antibiotic resistance in sexually transmitted diseases is a top concern for authorities and testing bodies across Europe, and now more laboratories can access our ResistancePlus tests for Mycoplasma genitalium and gonorrhoea to help address the real need for Resistance Guided Therapy.” The SpeeDx ResistancePlus portfolio includes ResistancePlus GC* (CE-IVD) - the first commercially available test that combines Neisseria gonorrhoeae (GC) detection with markers for ciprofloxacin susceptibility. ResistancePlus GC enables st

Nikon, ASML And Carl Zeiss Sign Agreement to Settle All Litigation23.1.2019 10:02Tiedote

Nikon Corporation (“Nikon”) (TYO: 7731), ASML Holding N.V. (“ASML”) (NASDAQ: ASML) and Carl Zeiss SMT GmbH (“Zeiss”) have signed a Memorandum of Understanding relating to a comprehensive settlement of all legal proceedings over patents for lithography equipment and digital cameras. The Memorandum of Understanding is a binding agreement that concerns all pending disputes between Nikon, ASML and Zeiss in Europe, Japan and the United States, including at the U. S. International Trade Commission. The three companies expect to execute a definitive settlement and cross-license agreement and dismiss all legal proceedings between the parties in February 2019. The terms of the Memorandum include a payment to Nikon by ASML and Zeiss of a total of EUR 150 million (approximately 19.0 billion Japanese Yen*). Furthermore, the cross-license agreement contemplated by the Memorandum includes mutual royalty payments of 0.8% over the sales of immersion lithography systems for 10 years from the signature

PMI Explores Global Public Health Issues in New White Paper23.1.2019 10:00Tiedote

In a new White Paper, “Public Health—Much Harder than Rocket Science,” Philip Morris International (PMI) (NYSE:PM) looks at the dynamics between consumers, corporations and authorities across a range of global public health issues. It is based on a recent global survey conducted by IPSOS. Consumers all over the world want their governments to do better at solving major public health issues, according to the IPSOS survey of 31,000 respondents across 31 countries commissioned by PMI. In the survey, respondents were asked how important they believed it is for governments to dedicate time and resources to nine global health issues: air pollution, mental health, STDs, healthier food products, opioid abuse, smoking and alcohol abuse, unwanted pregnancies and obesity. When asked about the role of technology and innovation in addressing these issues, 91 per cent of respondents believed technology and innovation had an important role to play. However, respondents did not evaluate government per

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