08:17 uur 04-02-2019

Chugai’s Hemlibra® krijgt een positief CHMP-advies bij ernstige hemofilie A zonder remmers

TOKYO–(BUSINESS WIRE)–Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) heeft vandaag aangekondigd dat Roche bericht heeft ontvangen dat het Europees Comitéa voor Medicinale Producten voor Menselijk Gebruik (CHMP) een positief advies heeft uitgebracht voor Hemlibra®. Dat is een door Chugai gecreëerde behandeling voor hemofilie A voor routinematige profylaxe van bloedingsepisodes bij volwassenen en kinderen met ernstige hemofilie A zonder factor-VIII-remmers. Het moet eenmaal per week, elke twee weken of elke vier weken worden toegediend. Het CHMP heeft ook een positief advies uitgebracht voor aanvullende doseringsopties van elke twee weken of elke vier weken bij volwassenen en kinderen met hemofilie A met factor-VIII-remmers.

“We zijn blij dat Hemlibra naar verwachting binnenkort zal worden goedgekeurd voor mensen met ernstige hemofilie A zonder remmers in de Europese Unie (EU)”, zei Chugai’s Executive Vice President en een van de leidinggevenden van de Project & Lifecycle Management Unit, Dr. Osamu Okuda.

Chugai’s Hemlibra® Gains Positive CHMP Opinion in Severe Hemophilia A Without Inhibitors

TOKYO–(BUSINESS WIRE)– Chugai Pharmaceutical Co., Ltd. (TOKYO:4519) announced today that Roche has received notification that the EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Hemlibra®, a treatment for hemophilia A created by Chugai, for routine prophylaxis of bleeding episodes in adults and children with severe hemophilia A without factor VIII inhibitors, administered once weekly, every two weeks, or every four weeks. The CHMP has also adopted a positive opinion for additional dosing options of every two weeks or every four weeks in adults and children with hemophilia A with factor VIII inhibitors.

“We are thrilled that Hemlibra is expected to be approved shortly for people with severe hemophilia A without inhibitors in the Europe Union (EU). Also, I’m very pleased that people in the EU with hemophilia A will soon be offered multiple options of Hemlibra’s dosing interval regardless of their inhibitor expression,” said Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit, Dr. Osamu Okuda. “Hemlibra is co-promoted by Chugai and Roche in Germany, France, and the United Kingdom, as is the case with the anti-rheumatic agent RoActemra®. We are committed to pursue our efforts in collaboration with Roche so that Hemlibra may further contribute to the treatment of hemophilia A.”

This positive opinion is based on results from two Phase III 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.

In Japan, Chugai obtained regulatory approval for Hemlibra from the Ministry of Health, Labour and Welfare in December 2018 for an additional indication of prophylactic treatment for people with hemophilia A without inhibitors to factor VIII, 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.

References

Chugai’s HEMLIBRA® Receives Regulatory Approval from U.S. FDA for Hemophilia A without Inhibitors
Press release issued on October 5, 2018
https://www.chugai-pharm.co.jp/english/news/detail/20181005100000_553.html

Chugai’s HEMLIBRA® Subcutaneous Injection Receives Approval for Hemophilia A without Inhibitors and Extension of Dosing Interval — HEMLIBRA is now available for Hemophilia A, regardless of inhibitor status –
Press release issued on December 21, 2018
https://www.chugai-pharm.co.jp/english/news/detail/20181221153002_580.html

About Severe Hemophilia A

People with severe hemophilia A is defined as the condition with less than 1 % of factor VIII levels. Hemophilia A affects around 320,000 people worldwide, 1,2 approximately 50-60% of whom are expected to have a severe form of the disorder3.

1) WFH. Guidelines for the management of haemophilia. 2012 [Internet; cited 2018 July]. Available from:
http://www1.wfh.org/publications/files/pdf-1472.pdf. (as of February 1, 2019)
2) Berntorp E, Shapiro AD. Modern haemophilia care. The Lancet 2012; 370:1447-1456.
3) Marder VJ, et al. Hemostasis and Thrombosis. Basic Principles and Clinical Practice. 6th Edition, 2013. Milwakee, Wisconsin. Lippincott Williams and Wilkin.

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.
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.

Contacts

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

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