DAYVIGO(lemborexant)

DAYVIGO (lemborexant) is a drug for which an NDA (Application Number 212028) was submitted on 12/27/2018 and received on the same date, undergoing a Standard Review with a PDUFA Goal Date of 12/27/2019. The application included 20 clinical studies, with 16 Phase 1 clinical pharmacology studies and 2 adequate and well-controlled Phase 3 studies. The recommended dose is 5 mg, with a maximum dose of 10 mg, available in 5 mg and 10 mg tablet strengths.

Lemborexant demonstrated statistically significant superiority to placebo on primary and key secondary efficacy endpoints. For lemborexant 5 mg, the LSGM ratio of sSOL (Month 6 / Baseline) was 0.73, and for lemborexant 10 mg, it was 0.70. The LS Mean Treatment Difference in sSE for lemborexant 5 mg vs placebo was 4.5%, and for lemborexant 10 mg vs placebo, it was 4.7%. The LS Mean Treatment Difference in sWASO for lemborexant 5 mg vs placebo was -17.5 minutes, and for lemborexant 10 mg vs placebo, it was -12.7 minutes.

Safety data included 1847 subjects exposed to lemborexant, with 708 subjects exposed for >=6 months and 434 subjects for 12 months. The incidence of somnolence/fatigue was 6.9% for lemborexant 5 mg and 9.6% for lemborexant 10 mg, compared to 1.3% for placebo. The Drug Liking Emax LSMean difference vs placebo was 11 points.