Idorsia Ltd — Quviviq FDA Review (NDA214985, ORIG 1, 2022)

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Idorsia's Daridorexant (Quviviq) for insomnia, an orexin receptor antagonist, received a multidisciplinary review team recommendation for approval (NDA 214985). Two pivotal Phase 3 trials (ID-078A301 and ID-078A302) demonstrated statistically significant and clinically meaningful improvements in primary efficacy endpoints: Wake After Sleep Onset (WASO) and Latency to Persistent Sleep (LPS), particularly with the 50mg dose. The safety profile is acceptable, with common adverse events including headache and nasopharyngitis, and potential CNS-depressant effects. While somnolence and next-day driving impairment were noted, serious adverse events were rare. The drug exhibits abuse potential similar to zolpidem and suvorexant, leading to a recommended Schedule IV classification. Pharmacokinetic studies informed dosing adjustments for hepatic impairment and drug-drug interactions. Post-marketing requirements and labeling changes are proposed to manage risks.

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