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Winlevi (clascoterone)
Australian Prescription Medicine Decision Summary
Sponsor
Device/Product name
Winlevi
Active Ingredient
Clascoterone
Date of decision
Published
Submission type
New chemical entity
ATC codes
D10AX06 (other anti-acne preparations for topical use)
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 Winlevi 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 | 28 February 2023 |
First round evaluation completed | 11 July 2023 |
Second round evaluation completed | 10 November 2023 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 18 December 2023 |
Advisory Committee meeting | February 2024 |
Registration decision (Outcome) | 9 March 2024 |
Completion of administrative activities and registration on ARTG | 12 March 2024 |
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
Black triangle scheme
Yes
Dose forms
White to almost white cream
Strength
10 mg/g
Other ingredients
Cetyl alcohol, citric acid monohydrate, disodium edetate, dl-alpha-tocopherol, mono- and di-glycerides, liquid paraffin, polysorbate 80, propylene glycol and purified water.
Containers
Epoxy-lined aluminium blind-end tube with a polypropylene cap closure.
Pack sizes
2 g, 10 g, 30 g and 60 g tubes
Routes of administration
Topical
Dosage
Thin layer applied twice a day to the entire area prone to acne.
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
Winlevi (clascoterone 1% w/w cream tube) was approved for the following therapeutic use:
Winlevi (clascoterone) cream is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.
What is this medicine and how does it work
Winlevi is a cream for acne that blocks androgen receptors. How it works is unclear. It may compete with the androgen dihydrotestosterone for the same receptors in the oil (sebaceous) glands and hair follicles. This reduces the signals that cause acne.
What post-market commitments will the sponsor undertake
Winlevi (Clascoterone) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicine Information (CMI) for WINLEVI 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.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.