Idorsia Pharmaceuticals Ltd: FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of adult patients with insomnia
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 wake signaling, is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.
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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
FDA accepts the new drug application for review of Idorsia s daridorexant for the treatment of apnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from apnews.com Daily Mail and Mail on Sunday newspapers.
Idorsia Pharmaceuticals Ltd: Idorsia announces financial results for 2020 - a successful year marked by outstanding clinical data
Idorsia Ltd (SIX: IDIA) today announced its financial results for the full year 2020.
Business highlights
Positive results in the Phase 3 program of daridorexant, demonstrating improved overall sleep and daytime functioning of patients with insomnia
Daridorexant new drug application (NDA) submitted to the US FDA on January 8, 2021
Positive results in the Japanese registration program for clazosentan, demonstrating reduction in vasospasm-related morbidity and all-cause mortality
US commercial operations established, with leadership team in place, and Syneos Health selected as commercialization partner to build the salesforce for the launch of daridorexant in the US