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346198, 346199 and 346200
346198, 346199 and 346200
346198, 346199 and 346200
Device/Product name
Active Ingredient
Date of decision
Submission type
New biological entity
ATC codes
What was the decision based on
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Rybelsus was considered favourable for the therapeutic use approved.
What steps were involved in the decision process

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

Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
3 mg, 7 mg and 14 mg
Other ingredients
Salcaprozate sodium, povidone, microcrystalline cellulose, and magnesium stearate
Blister pack
Pack sizes
10 (excluding 3 mg), 30, 60 and 90
Routes of administration

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.

Pregnancy category
DDrugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved

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.
What is this medicine and how does it work
Semaglutide is a glucagon like peptide-1 (GLP 1) analogue with 94% sequence homology to human GLP 1. Semaglutide acts as a GLP-1 receptor agonist that binds to and activates the GLP 1 receptor, the target for native GLP 1. GLP 1 is a physiological hormone that has multiple actions in glucose and appetite regulation, and in the cardiovascular system. The glucose and appetite effects are specifically mediated via GLP 1 receptors in the pancreas and the brain. GLP 1 receptors are also expressed in the heart, vasculature and immune system and kidney from where it may mediate cardiovascular and microvascular effects. Compared to native GLP 1, semaglutide has a prolonged half-life of around one week. The principal mechanism of protraction is albumin binding, which results in decreased renal clearance and protection from metabolic degradation. Furthermore, semaglutide is stabilised against degradation by the dipeptidyl peptidase 4 (DPP 4) enzyme. Semaglutide reduces blood glucose through a mechanism where it stimulates insulin secretion and lowers glucagon secretion, both in a glucose dependent manner. Thus, when blood glucose is high, insulin secretion is stimulated, and glucagon secretion is inhibited. The mechanism of blood glucose lowering also involves a minor delay in gastric emptying in the early postprandial phase. During hypoglycaemia semaglutide diminishes insulin secretion and does not impair glucagon secretion. Semaglutide reduces body weight and body fat mass through lowered energy intake, involving an overall reduced appetite, which includes increased satiety and reduced hunger, as well as improved control of eating and decreased food cravings. Insulin resistance is also reduced, probably through reduction in body weight. In addition, semaglutide reduces the preference for high fat foods. Semaglutide had a beneficial effect on plasma lipids, lowered systolic blood pressure and reduced inflammation in clinical studies. In animal studies, semaglutide attenuates the development of atherosclerosis by preventing aortic plaque progression and reducing inflammation in the plaque.
What post-market commitments will the sponsor undertake
  • 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.

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