Dayvigo
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 June 2020 |
| First round evaluation completed | 1 December 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 29 January 2021 |
| Second round evaluation completed | 5 March 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 6 May 2021 |
| Sponsor's pre-Advisory Committee response | 21 May 2021 |
| Advisory Committee meeting | 3 and 4 June 2021 |
| Registration decision (Outcome) | 15 July 2021 |
| Completion of administrative activities and registration on ARTG | 16 July 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 224 |
*Statutory timeframe for standard applications is 255 working days
The recommended dose of Dayvigo is 5 mg, taken no more than once per night and within a few minutes before going to bed, with at least 7 hours remaining before the planned time of awakening. If the 5 mg dose is well tolerated but greater effect is needed, the dose can be increased to 10 mg once daily, the maximum recommended dose. Dayvigo should be used at the lowest dose and for the shortest duration as clinically indicated.
For further information refer to the Product Information.
Dayvigo (lemborexant) was approved for the following therapeutic use:
Dayvigo is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest DSM criteria
- Dayvigo (lemborexant) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Dayvigo must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Dayvigo Canadian-risk management plan (RMP) (version 1.0, dated 25 August 2019, data lock point 11 January 2019), with Australian specific annex (version 2.0, dated 27 January 2021), included with submission PM-2020-02421-1-1, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of RMP is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the European Union (EU) during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- Submit the study report of in vitro drug-drug interaction (DDI) study to assess the potential of lemborexant as an inducer for cytochrome P450 family 2 subfamily C member 8 (CYP2C8), cytochrome P450 family 2 subfamily C member 9 (CYP2C9) and cytochrome P450 family 2 subfamily C member 19 (CYP2C19).
- Submit the study report of in vitro DDI study to assess the potential of lemborexant as an P‑glycoprotein substrate at clinically relevant concentrations.