Eisai's Resubmitted NDA for Anticancer Agent Halaven Accepted in China

TOKYO, Nov 30, 2017 - (JCN Newswire) - Eisai Co., Ltd. announced today that the China Food and Drug Administration (CFDA) has accepted for review the resubmitted New Drug Application (NDA) for Eisai's anticancer agent eribulin mesylate (eribulin, product name: Halaven).

In July 2016, Eisai submitted an NDA for eribulin for use in the treatment of locally advanced or metastatic breast cancer in China. However, in alignment with Chinese regulations, Eisai temporarily withdrew its application in June 2017 in order to submit additional documentation. The application was resubmitted once preparations of additional documentation were completed.

Eisai positions oncology as a key therapeutic area, and is aiming to discovery revolutionary new medicines with the potential to cure cancer. Eisai remains committed to maximizing the clinical value as well as exploring the potential clinical benefits of Halaven as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers in China and around the world.

About Eisai

Eisai Co., Ltd. (TSE:4523; ADR:ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.

Contact:
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120

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