Posted by Michael Wonder on 11 Mar 2019
Eisai and Imbrium Therapeutics announce U.S. FDA filing acceptance of new drug application for lemborexant for the treatment of insomnia
11 March 2019 - Eisai Co and Imbrium Therapeutics today announced that the U.S. FDA has accepted for review the new drug application for lemborexant, an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder.
A Prescription Drug User Fee Act date is set for 27 December 2019.
The submission was based on data from the clinical development program including two pivotal Phase 3 studies of lemborexant – SUNRISE 1 (Study 304) and SUNRISE 2 (Study 303).
