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Review
. 2022 Apr;82(5):601-607.
doi: 10.1007/s40265-022-01699-y.

Daridorexant: First Approval

Anthony Markham  1
Affiliations
Review

Daridorexant: First Approval

Anthony Markham. Drugs. 2022 Apr.

Erratum in

Abstract

Daridorexant (Quviviq™; Idorsia Pharmaceuticals Ltd.) is an orally administered dual orexin type 1 and type 2 (OX1 and OX2) receptor antagonist (DORA) being developed for the treatment of insomnia. It was selected from a pool of drug candidates on the basis of an expected effect duration of ≈ 8 h at a dose of 25 mg, with a half-life intended to minimize residual effects that might impair daytime functioning. Based on the results of two pivotal phase III trials, daridorexant was recently approved in the USA for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. This article summarizes the milestones in the development of daridorexant leading to this first approval.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. A. Markham is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Figures

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Key milestones in the development of daridorexant for the treatment of insomnia. EMA European Medicines Agency, FDA Food and Drug Administration, MAA Marketing Authorisation Application, NDA New Drug Application
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Chemical structure of daridorexant
See this image and copyright information in PMC

References

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    1. Muehlan C, Heuberger J, Juif PE, et al. Accelerated development of the dual orexin receptor antagonist ACT-541468: integration of a microtracer in a first-in-human study. Clin Pharmacol Ther. 2018;104(5):1022–1029. doi: 10.1002/cpt.1046. - DOI - PubMed
    1. GlobeNewswire. Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for the treatment of adults with insomnia [media release]. 10 Jan 2022. https://www.globenewswire.com/news-release/2022/01/10/2363527/0/en/Idors....
    1. European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022 [media release]. 25 Feb 2022. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal....
    1. Idorsia Pharmaceuticals US Inc. QUVIVIQ (daridorexant) tablets, for oral use, [controlled substance schedule pending] US prescribing information. 2022. https://www.idorsia.us/documents/us/label/Quviviq_PI.pdf. Accessed 14 Feb 2022

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