FDA grants priority review status to Eisai's eribulin NDA

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted priority review status to the company's New Drug Application (NDA) for the investigational agent eribulin mesylate ("eribulin," also known as E7389). Eisai is seeking FDA approval for eribulin in the treatment of patients with locally advanced or metastatic breast cancer previously treated with at least two chemotherapy regimens, including an anthracycline and a taxane.

FDA grants priority review status to those drugs that if approved, have the potential to provide, in the treatment, prevention, or diagnosis of a disease, one of the following: (1) safe and effective therapy where no satisfactory alternative therapy exists; or (2) a significant improvement compared to marketed products. The goal for completing a review of an NDA with priority review status is six months compared with the standard 10-month time frame.

Eisai submitted simultaneous regulatory applications for the approval of eribulin in the U.S., Japan and the European Union (EU) on March 30, 2010. The company also has submitted regulatory applications for approval to health authorities in Switzerland and Singapore.

Eisai defines oncology as a therapeutic area of focus and is committed to developing novel anti-cancer agents and treatments for supportive care. With these efforts, Eisai seeks to further address the diversified needs of patients and families affected by cancer as well as healthcare professionals.