Chugai’s HEMLIBRA® Receives Regulatory Approval from U.S. FDA for Hemophilia A Without Inhibitors


TOKYO–(BUSINESS WIRE)–#biotechChugai
Pharmaceutical Co., Ltd.
(TOKYO:4519) announced today that the U.S.
Food and Drug Administration (FDA) has approved HEMLIBRA® (US
generic name: emicizumab-kxwh), a treatment for hemophilia A created by
Chugai, for routine prophylaxis to prevent or reduce the frequency of
bleeding episodes in adults and children, ages newborn and older, with
hemophilia A without factor VIII inhibitors, administered once weekly,
every two weeks, or every four weeks. The FDA has also approved
additional dosing options of every two weeks or every four weeks in
adults and children with hemophilia A with factor VIII inhibitors. The
US application was submitted by Genentech,
a member of Roche Group.

“We are very pleased that HEMLIBRA has obtained its first regulatory
approval for people with hemophilia A without inhibitors,” said Chugai’s
President & CEO, Tatsuro Kosaka. “Now people with hemophilia A in the US
can be offered flexibility in HEMLIBRA’s dosing interval from multiple
options depending on their needs, regardless of their inhibitor
expression. We anticipate that HEMLIBRA will make an even greater
contribution to the advancement of treatment of hemophilia A.”

This regulatory approval is based on results from two Phase lll studies
HAVEN 3 (NCT02847637) and HAVEN 4 (NCT03020160), conducted jointly with
Roche and Genentech. HAVEN 3 study was conducted to evaluate the
reduction of bleed rate 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. HAVEN 4 study was conducted to
evaluate efficacy, safety, and pharmacokinetics of HEMLIBRA subcutaneous
injection every four weeks in people with hemophilia A (12 years of age
or older), with and without inhibitors to factor VIII.

HEMLIBRA was granted Priority Review and Breakthrough Therapy
Designation by the FDA in hemophilia A without inhibitors, following the
prior designations in hemophilia A with inhibitors. Priority Review
designation is granted to medicines that the FDA has determined to have
the potential to provide significant improvements in the safety and
effectiveness of the treatment, prevention or diagnosis of a serious
disease. In Japan and the EU, applications have been filed to regulatory
authorities and are currently under review for an additional indication
of prophylactic treatment for people with hemophilia A without
inhibitors, as well as for additional dosage and administration as a
biweekly or every four-week treatment for people with hemophilia A with
inhibitors to factor VIII.

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.


For Media
Chugai Pharmaceutical Co.,
Media Relations Group, Corporate Communications Dept.,
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
US media

Chugai Pharma USA Inc.
Casey Astringer
E-mail: pr@chugai-pharm.com
European media

Chugai Pharma France SAS
Nathalie Leroy
E-mail: pr@chugai.eu
Taiwanese media

Chugai Pharma Taiwan Ltd.
Susan Chou
E-mail: pr@chugai.com.tw

Chugai Pharmaceutical Co., Ltd.
Relations Group, Corporate Communications Dept.,
Toshiya Sasai
E-mail: ir@chugai-pharm.co.jp


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