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Aklief
Published
Product name
Aklief
Active ingredient
Trifarotene
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
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.
How this medicine works
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.
Why the TGA approved or did not approve this medicine
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.
Sponsor