Rybelsus
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 2 November 2020 |
| First round evaluation completed | 31 March 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 1 June 2021 |
| Second round evaluation completed | 15 July 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 2 November 2021 |
| Sponsor's pre-Advisory Committee response | 10 November 2021 |
| Advisory Committee meeting | 2 and 3 December 2021 |
| Registration decision (Outcome) | 4 February 2022 |
| Completion of administrative activities and registration on ARTG | 7 February 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 203 |
*Statutory timeframe for standard applications is 255 working days
The starting dose of Rybelsus is 3 mg once daily for one month. After one month, the dose should be increased to a maintenance dose of 7 mg once daily. After at least one month on a dose of 7 mg once daily, the dose can be increased to a maintenance dose of 14 mg once daily to further improve glycaemic control.
The maximum recommended single daily dose of Rybelsus is 14 mg. Taking two 7 mg tablets to achieve the effect of a 14 mg dose has not been studied and is therefore not recommended.
Rybelsus can be used as monotherapy or in combination with one or more glucose lowering medicinal products (see Section 4.2 Dose and Method of Administration - Dosage adjustment of the product information).
For further information refer to the Product Information.
Rybelsus (semaglutide) was approved for the following therapeutic use:
Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
- as monotherapy if metformin is considered inappropriate due to intolerance or contraindications; or
- in combination with other medicinal products for the treatment of type 2 diabetes mellitus.
- Rybelsus (semaglutide) is to be included in the Black Triangle Scheme. The [Product Information] PI and [Consumer Medicines Information] CMI for Rybelsus 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 Rybelsus [European Union] EU-risk management plan (RMP) (version 4.4, dated 6 April 2020, data lock point 2 November 2018), with Australian specific annex (version 1.2, dated 30 August 2021), included with Submission PM 2020 03921 1 5, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs 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 ([revision] 1), part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.