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Press Release : FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of adult patients with insomnia

Message : Required fields 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 Allschwil, Switzerland March 10, 2021 Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for review of Idorsia s investigational dual orexin receptor antagonist, daridorexant, for the treatment of adult patients with insomnia. Insomnia is a common problem with approximately 25 million adults in the US who meet the diagnostic criteria. Insomnia, a condition of overactive

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