Eisai Co., Ltd. — Dayvigo FDA Review (NDA212028, ORIG 1, 2019)
Eisai Co., Ltd. · 2019 · FDA Review (openFDA) · company profile →
Report summary
Eisai Co., Ltd.'s New Drug Application (NDA) 212028 for DAYVIGO (lemborexant) for insomnia treatment is recommended for approval. Two pivotal trials (Study 303 and 304) demonstrated significant efficacy in improving sleep onset and maintenance. The recommended starting dose is 5 mg nightly, increasing to 10 mg based on clinical response. Nonclinical studies support approval, with toxicology findings including GI, hematological, and liver effects in monkeys, and bone/teeth toxicity in rats. Carcinogenicity studies were negative. Lemborexant, an orexin receptor antagonist, is primarily metabolized by CYP3A4/5. Key safety concerns include somnolence/fatigue, headache, nightmares, sleep paralysis, hypnagogic hallucinations, and complex sleep behaviors. While no significant cardiovascular or suicidality signals were found, dose-related somnolence and next-day impairment were observed, particularly in elderly patients. A human abuse potential study suggested lemborexant's abuse potential is similar to zolpidem but greater than suvorexant. Post-marketing studies are required for respiratory safety in OSA/COPD patients.
Key findings — cited to the page
| Application Type | NDA | DAYVIGO (lemborexant) · p.2 |
| Received Date | 12/27/2018 | DAYVIGO (lemborexant) · p.2 |
| Approval Year | 2010 | Silenor · p.36 |
| Application Number | 212028 | DAYVIGO (lemborexant) · p.2 |
| Priority or Standard Review | Standard | DAYVIGO (lemborexant) · p.2 |
| Submit Date | 12/27/2018 | DAYVIGO (lemborexant) · p.2 |
| Approval Year | 1969 | Doxepin · p.36 |
| Peak mean response for 30 mg zolpidem (Drug Liking VAS) | 66.2 | E2006-a001-103 · p.332 |
| Peak mean response for 10 mg lemborexant (Drug Liking VAS) | 68.4 | E2006-a001-103 · p.332 |
| Peak mean response for 20 mg lemborexant (Drug Liking VAS) | 70.1 | E2006-a001-103 · p.332 |
| Peak mean response for 30 mg lemborexant (Drug Liking VAS) | 71.8 | E2006-a001-103 · p.332 |
| PDUFA Goal Date | 12/27/2019 | DAYVIGO (lemborexant) · p.2 |
Source: Eisai Co., Ltd. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →