Eisai’s Dayvigo (lemborexant) Receives the US FDA’s Approval to Treat Insomnia in Adults

 Eisai’s Dayvigo (lemborexant) Receives the US FDA’s Approval to Treat Insomnia in Adults

Eisai Signs a Research Collaboration with BioArctic to Characterize BAN2401’s Mechanism of Action

Shots:

  • The approval is based on two P-III studies (study 1 & 2) assessing Dayvigo (5mg/10mg, once nightly) vs PBO in patients aged ≥18yrs. & in female patients aged ≥55yrs. and male aged≥65yrs. for 6mos. & 1mos. who met DSM-5 criteria for insomnia disorder respectively
  • The collaborative results indicated that Dayvigo demonstrated superiority sSOL, sSEF, sWASO, LPS, SEF and WASO, effect at the beginning of treatment were generally consistent with later timepoints
  • The FDA has recommended Dayvigo to be classified as a controlled substance while recommendation has been submitted to the US DEA. Dayvigo is expected to be commercially available within 90days following DEA scheduling

Cclick here to read full press release/ article | Ref: Eisai | Image: Twitter

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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