Eisai makes simultaneous regulatory filings for eribulin in Japan, USA and EU

Japanese drug major Eisai said yesterday that it has submitted simultaneous regulatory applications for approval of eribulin mesylate (also known as E7389) for the treatment of locally-advanced or metastatic breast cancer to agencies in Japan, the USA and the European Union.

Eribulin, a non-taxane microtubule dynamics inhibitor, is an investigational chemical compound discovered and developed by Eisai, is viewed as having blockbuster sales potential. The company itself said it expects revenues of more than $1 billion a year, and that it hopes to start rolling it out during the current fiscal year which begins today.

The move comes less than a week after the company revealed that it has postponed its target deadline to seek approval in all three market regions for another potential future earnings pillar, Eritoran for sepsis, by six months to March 2011.