We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Aklief
Sponsor
ARTGs
340375, 332220
340375, 332220
Device/Product name
Aklief
Active Ingredient
Trifarotene
Date of decision
Published
Submission type
New chemical entity
ATC codes
D10AD06
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 Aklief 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 comparable overseas regulator approach B (COR-B) application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 April 2020 |
| First round evaluation completed | 28 August 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 21 September 2020 |
| Second round evaluation completed | 15 October 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 3 November 2020 |
| Sponsor's pre-Advisory Committee response | 12 November 2020 |
| Advisory Committee meeting | 4 December 2020 |
| Registration decision (Outcome) | 11 January 2021 |
| Completion of administrative activities and registration on ARTG | 18 January 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 166 |
*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
Cream
Strength
50 µg/g
Other ingredients
Allantoin, simulgel 600 PHA (acrylamide/sodium acryloyldimethyltaurate copolymer, isohexadecane, polysorbate 80, sorbitan oleate), cyclomethicone, ethanol, phenoxyethanol, propylene glycol, medium chain triglycerides, purified water
Containers
Tube and bottle
Pack sizes
1 tube of 5 g; 1 bottle of 15g, 30g or 75g
Routes of administration
Topical
Dosage
Apply a thin layer of Aklief cream to the affected areas of the face and/or trunk once a day, in the evening, on clean and dry skin.
It is recommended that the physician assesses the continued improvement of the patient after three months of treatment. The duration of treatment should be determined by the doctor based on the clinical response.
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
Aklief (trifarotene) was approved for the following therapeutic use:
Aklief is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.
What is this medicine and how does it work
Aklief cream contains 50 µg/g (w/w) trifarotene, which is a chemically stable, terphenyl acid derivative with retinoid-like activity. It is a relatively potent retinoid acid receptor γ (RARγ) agonist, characterised by its high specificity to this receptor over RARα and RARβ (65- and 16-fold, respectively, with no retinoid X receptor (RXR) activity).In addition, trifarotene modulates retinoid target genes (differentiation and inflammatory processes) in human immortalised keratinocytes and human reconstructed epidermis.
What post-market commitments will the sponsor undertake
- Aklief (trifarotene) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Aklief 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 Aklief Eruopean Union (EU)-Risk Management Plan (RMP) (version 1.3, dated 9 December 2019; data lock point (DLP) 14 March 2018), with Australian Specific Annex (version 1.1, August 2020), included with submission PM-2020-01095-1-1, 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).
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 this 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 this 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.
Once the EU reference dates are available, reports are to be provided in line with the 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 this 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.