|Thursday, 30 November 2017, 08:41 HKT/SGT|
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.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our human health care philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Oncology and Neurology.
As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.
For more information about Eisai Co., Ltd., please visit www.eisai.com.
Public Relations Department,
Eisai Co., Ltd.
Nov 30, 2017 08:41 HKT/SGT
Eisai (TSE: 4523)
Topic: Press release summary
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