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Mounjaro
Sponsor
ARTGs
Device/Product name
Mounjaro
Active Ingredient
Tirzepatide
Date of decision
Published
Submission type
New chemical entity
ATC codes
A10BX16
Decision
Approved
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 Mounjaro 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.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland-United Kingdom (ACCESS) Consortium, with work-sharing between TGA, Health Canada and Swissmedic. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
|
Description |
Date |
|
Submission dossier accepted and first round evaluation commenced |
14 January 2022 |
|
First round evaluation completed |
13 May 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
29 June 2022 |
|
Second round evaluation completed |
26 August 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
31 October 2022 |
|
Sponsor’s pre-Advisory Committee response |
9 November 2022 |
|
Advisory Committee meeting |
1 and 2 December 2022 |
|
Registration decision (Outcome) |
22 December 2022 |
|
Completion of administrative activities and registration on ARTG |
23 December 2022 |
|
Number of working days from submission dossier acceptance to registration decision* |
194 |
*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
Solution for injection
Strength
2.5 mg/0.5 mL, 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL,15 mg/0.5 mL
Other ingredients
Dibasic sodium phosphate heptahydrate, hydrochloric acid, sodium chloride, sodium hydroxide, and water for injections
Containers
Pre-filled pen
Pack sizes
2 and 4 for 5 mg/0.5 mL, 7.5 mg/0.5 mL, 10 mg/0.5 mL, 12.5 mg/0.5 mL, and 15 mg/0.5 mL; 2, 4 and 2 (starter pack) for 2.5 mg/0.5 mL
Routes of administration
Subcutaneous
Dosage
The starting dose of tirzepatide is 2.5 mg once weekly. After 4 weeks, increase the dose to 5 mg once weekly.
If needed, dose increases can be made in 2.5 mg increments after a minimum of 4 weeks on the current dose. The recommended doses are 5 mg, 10 mg and 15 mg. The 2.5 mg, 7.5 mg and 12.5 mg are not maintenance doses.
The maximum dose of tirzepatide is 15 mg once weekly.
For further information refer to the Product Information.
Pregnancy category
D
Drugs 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.
Drugs 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
Mounjaro (tirzepatide) was approved for the following therapeutic use:
Type 2 Diabetes Mellitus:
Mounjaro is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise
- as monotherapy when metformin is not tolerated or contraindicated.
- in addition to other medicinal products for the treatment of type 2 diabetes.
What is this medicine and how does it work
Tirzepatide is a long-acting dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It is a 39-amino acid peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs half-life. Both receptors are present on the pancreatic α and β endocrine cells, brain, heart, vasculature, immune cells (leukocytes), gut and kidney. GIP receptors are also present on adipocytes.
Tirzepatide is selective to human GIP and GLP-1 receptors. Tirzepatide has high affinity to both the GIP and GLP-1 receptors. The activity of tirzepatide on the GIP receptor is similar to native GIP hormone. The activity of tirzepatide on the GLP-1 receptor is lower compared to native GLP 1 hormone. Tirzepatide is a biased agonist at the GLP-1 receptor with preferential signaling towards the activation of adenylyl cyclase as opposed to the recruitment of β-arrestin.
Tirzepatide is selective to human GIP and GLP-1 receptors. Tirzepatide has high affinity to both the GIP and GLP-1 receptors. The activity of tirzepatide on the GIP receptor is similar to native GIP hormone. The activity of tirzepatide on the GLP-1 receptor is lower compared to native GLP 1 hormone. Tirzepatide is a biased agonist at the GLP-1 receptor with preferential signaling towards the activation of adenylyl cyclase as opposed to the recruitment of β-arrestin.
What post-market commitments will the sponsor undertake
- Mounjaro (tirzepatide) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Mounjaro 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 Tirzepatide EU [European Union]-risk management plan (RMP) (version 0.3, dated 27 June 2022, data lock point 2 June 2021), with Australia specific annex (version 1.1, dated 12 August 2022), included with Submission PM-2021-05212-1-5, to be revised to the satisfaction of the TGA, and any subsequent revisions, 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).
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 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 (revision 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.
- For all injectable products the Product Information must be included with the product as a package insert.