Posted by Michael Wonder on 10 Mar 2021
FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia
10 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 favorable safety profile.
Idorsia today announced that the US FDA has accepted the new drug application for review of Idorsia’s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia.
