Chemistry:Trifarotene
Trifarotene, sold under the brand name Aklief, is a medication for the topical treatment of acne vulgaris.[1][2] It is a retinoid;[1][3] specifically, a fourth-generation selective retinoic acid receptor (RAR)-γ agonist.[4]
Trifarotene was granted orphan drug designation for the treatment of congenital ichthyosis by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).[5][6] It was approved for medical use in the United States in October 2019.[2][7][8] In December 2019, its labelling and package leaflet text received a decentralised approval for 16 European countries.[9]
Medical uses
In the United States, trifarotene is indicated for the topical treatment of acne vulgaris in people nine years of age and older.[1] In both Canada and Australia, it is indicated for the topical treatment of acne vulgaris of the face and/or the trunk in people twelve years of age and older.[10][11][12]
Side effects
Most adverse effects of topical trifarotene for the treatment of acne are at the location site and transient, such as application site irritation, allergic dermatitis, skin irritation and sunburn.[13] Even though systemic absorption is very low,[14] use of trifarotene is still contraindicated during pregnancy[15] because of the known risk of teratogenicity of the overall class of drugs trifarotene belongs to, retinoids.
Society and culture
Legal status
Trifarotene was approved for medical use in the United States in October 2019,[8] in Canada in November 2019,[12] and in Australia in January 2021.[10][11]
References
- ↑ 1.0 1.1 1.2 Cite error: Invalid
<ref>tag; no text was provided for refs namedAklief FDA label - ↑ 2.0 2.1 "Drug Trials Snapshots: Aklief". 11 October 2019. https://www.fda.gov/drugs/resources-information-approved-drugs/drug-trials-snapshots-aklief.
This article incorporates text from this source, which is in the public domain.
- ↑ "Trifarotene Monograph for Professionals". 28 October 2019. https://www.drugs.com/monograph/trifarotene.html.
- ↑ "Trifarotene: First Approval". Drugs 79 (17): 1905–09. November 2019. doi:10.1007/s40265-019-01218-6. PMID 31713811. http://link.springer.com/10.1007/s40265-019-01218-6. Retrieved 17 June 2020.
- ↑ "Trifarotene Orphan Drug Designations and Approvals". 24 December 1999. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=20144310.
- ↑ "EU/3/20/2264". 12 August 2020. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202264.
- ↑ "Aklief (trifarotene) FDA Approval History". 7 October 2019. https://www.drugs.com/history/aklief.html.
- ↑ 8.0 8.1 "Drug Approval Package: Aklief". 21 October 2019. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211527Orig1s000TOC.cfm.
- ↑ "Galderma receives a positive outcome through the European Decentralised Procedure for Aklief (trifarotene 50 mcg/g cream), the first new retinoid molecule for acne in the European Union in 25 years" (Press release). Galderma. 20 December 2019. Archived from the original on 24 May 2021. Retrieved 24 May 2021 – via Business Wire.
- ↑ 10.0 10.1 Cite error: Invalid
<ref>tag; no text was provided for refs namedAklief TGA label - ↑ 11.0 11.1 Cite error: Invalid
<ref>tag; no text was provided for refs namedAklief APM summary - ↑ 12.0 12.1 Cite error: Invalid
<ref>tag; no text was provided for refs namedAklief Health Canada label - ↑ "Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne" (in English). Journal of the American Academy of Dermatology 80 (6): 1691–1699. June 2019. doi:10.1016/j.jaad.2019.02.044. PMID 30802558.
- ↑ "Clinical Pharmacology and Safety of Trifarotene, a First-in-Class RARγ-Selective Topical Retinoid". Journal of Clinical Pharmacology 60 (5): 660–668. May 2020. doi:10.1002/jcph.1566. PMID 32017149.
- ↑ "Trifarotene for acne". Australian Prescriber 44 (4): 140–141. August 2021. doi:10.18773/austprescr.2021.033. PMID 34421181.
 |  |
