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
Lausanne, Switzerland, December 20th 2019 – Galderma today announced that AKLIEF® (trifarotene 50 mcg/g cream) has concluded its European decentralised procedure resulting in the approval of its summary of product characteristics, package leaflet, and labelling, by all involved European member states. Each of the 16 concerned member states will now issue individual national marketing authorisations for the cutaneous 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 pustules are present. Once approved, trifarotene 50 mcg/g cream will be the first new retinoid molecule launched in the European Union in 25 years.1
“Although retinoids are the cornerstone of acne treatment, there have been few significant advances or developments in decades,” said Professor Thomas Dirschka, University of Witten-Herdecke, Germany. “It is encouraging to see innovative approaches to tackling one of the most common and frustrating skin diseases.”
“Truncal acne can affect almost half of those with facial acne. It often goes under-reported and underdiagnosed, despite a desire from patients to have it treated,” said Professor Jerry Tan, University of Western Ontario, Windsor, ON, Canada. “To date, there has been a lack of scientific evidence on the management of truncal acne and as such, it is important to investigate new treatment options that specifically address this unmet need.”
Trifarotene 50 mcg/g cream is the first treatment to selectively target retinoic acid receptor gamma (RAR-g), the most common RAR found in the skin.2,3,4 Trifarotene 50 mcg/g cream was assessed by regulators on data from two large, randomised Phase III clinical trials (PERFECT 1 & 2). Data have demonstrated that the systemic exposure of AKLIEF® cream is low as it is rapidly metabolised in the liver, with a half-life of just five minutes.3 Therefore, as well as treating facial acne, it can be used on large body surface areas of the trunk.3
“Acne can severely impact the quality of life and psychological well-being of those who suffer from it. The approval of AKLIEF® will provide patients across Europe with a next-generation retinoid cream that has been shown to be fast and effective at treating acne on both the face and trunk,” said Dr Thibaud Portal, Galderma Global Vice President of Prescription Medicines. “This underscores Galderma’s commitment to providing innovative solutions for the most common and frustrating skin diseases.”
Trifarotene 50 mcg/g cream has been shown to significantly reduce inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared with vehicle (control) (p<0.001).2 Trifarotene 50 mcg/g cream was well tolerated on the face and trunk. Treatment-related adverse events included mild-to-moderate application site reactions, such as skin irritation, mainly characterised by scaling, dryness, erythema and burning/stinging.2
Acne is one of the most common skin disorders and affects approximately 70 million people across Europe.5 Acne can occur on the face and trunk (shoulders, back and chest)6,7 and it is estimated that around half of people with facial acne also have truncal acne.7 Despite the clear need for treatments that target both facial and truncal acne, there has been a lack of scientific evidence on the management of truncal acne, with the majority of studies focusing on the treatment of facial acne alone.8,9
In the European Union, AKLIEF® (trifarotene 50 mcg/g cream) is indicated for the cutaneous 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 pustules are present. It is the only topical retinoid that specifically targets retinoic acid receptor gamma (RAR-γ), the most common RAR in the skin.3,4 National marketing authorisations across concerned European member states will follow in 2020.
AKLIEF® received approval from the US Food and Drug Administration (FDA) in October 201910 It also received approval from Health Canada in November 2019.11
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com
Sébastien Cros, Head of Corporate Communications [email protected]
- EMA. List of European Union reference dates frequency of submission of periodic safety update reports. Available at https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports-psurs (Last access December 2019)
- Tan J, et al. J Am Acad Dermatol 2019;80(6):1691–9.
- Aubert J, et al. Br J Dermatol 2018;179:442–56.
- Fisher GJ, et al. J Biol Chem 1994;269(32):20629–35.
- Hay RJ, et al. J Invest Dermatol 2014;134(6 Suppl 1):S2.
- Dréno B, et al. J Eur Acad Dermatol Venereol 2015;291096-1106.
- Del Rosso JQ, et al. J Drugs Dermatol 2007;6(6):597–600.
- Liu CW & Tan J. Skin Therapy Lett 2017;12.
- Asai Y, et al. CMAJ 2016;188:118–26.
- FDA. Approval of Aklief. Available at: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2019 (Last access December 2019)
- Health Canada. Approval of Aklief. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs/register.html (last access December 2019)