3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on objective and subjective sleep parameters, and an improvement in daytime functioning, while maintaining a favourable safety profile.
Idorsia today announced the submission of a marketing authorisation application to the EMA for daridorexant, Idorsia's investigational dual orexin receptor antagonist, for the treatment of adult patients with insomnia.