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Results of Global Phase III Study with Chugai's HEMLIBRA® for Hemophilia A Without Inhibitors Published in the New England Journal of Medicine

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Chugai
Pharmaceutical Co., Ltd.
(TYO: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.

Reference

Chugai Presents Results of Two Pivotal Phase III Studies for its
Bispecific Antibody HEMLIBRA at WFH 2018 (Press release issued on May
21, 2018)
https://www.chugai-pharm.co.jp/english/news/detail/20180521160000.html

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 totalled 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.

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

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