Eisai Co., Ltd. announced today that, in alignment with Chinese regulations, it has temporarily withdrawn its new drug application for anticancer agent eribulin mesylate (Brand name: Halaven) in China in order to submit additional documentation.
No additional clinical trials have been scheduled, and resubmission will take place as soon as the additional documentation is prepared.
In July 2016, Eisai submitted a new drug application for Halaven seeking approval as a treatment for locally advanced or metastatic breast cancer. Eisai is working closely with the regulatory authority in China for resubmission of this application as quickly as possible in order to contribute to breast cancer patients and their families in China.
Eisai Co., Ltd. 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.
Public Relations Department,
Eisai Co., Ltd.