First New Retinoid Molecule Approved in Over 20 Years
Next-generation retinoid, AKLIEF® trifarotene cream 50 mcg/g is proven effective
in both facial and truncal acne treatment
THORNHILL, ON, Nov. 28, 2019 /CNW/ - Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that Health Canada approved AKLIEF® trifarotene cream, 50 mcg/g (AKLIEF) for the topical treatment of acne of the face and/or trunk in patients 12 years of age and older.
AKLIEF is the first new retinoid molecule to receive Health Canada approval for the treatment of acne in more than 20 years.1, 2, 3, 4 It is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.5,6,7 Also, AKLIEF is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne, offering healthcare professionals and Canadian acne patients another treatment option.3
"This new approval marks an important milestone in effectively treating acne in Canada, especially truncal acne," says Dr. Melinda Gooderham, a dermatologist and Medical Director at the SKiN Centre for Dermatology and the SKiN Research Centre in Peterborough, Ontario. "This next generation retinoid is exciting news for physicians and patients. The clinical evidence demonstrates that AKLIEF reduces inflammatory lesions on the face, back and chest while delivering low systemic levels. This ensures efficacy, safety and tolerability which makes AKLIEF particularly useful for the treatment of acne lesions that appear on large surfaces of the skin, like the back and chest of some acne patients."
About the Phase III Clinical Trials
The Health Canada approval of AKLIEF is supported by data from the two pivotal Phase 3 clinical trials of once-daily AKLIEF in patients with moderate acne on the face and trunk.3 The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that AKLIEF significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05).3 AKLIEF was well tolerated when used on the face, back, shoulders and chest.3
"The approval of AKLIEF is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne," said Thibaud Portal PhD, Galderma Global Vice President, Prescription. "We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments."
AKLIEF is expected to be available in Canada in January 2020 by prescription only. It will be provided in a 75 gram pump.
Acne is the most common skin disease in Canada, affecting up to 5.6 million Canadians annually and approximately 80 per cent of young people.8 It occurs when pores become clogged by dead skin cells resulting in accumulation of sebum, an oily substance produced by oil glands.7 Bacteria within pores, called Cutibacterium acnes (C. acnes), can contribute to pore blockage and inflammation – visible as redness, swelling and pus that may accompany acne spots.7 Acne on the face is the most common and often the most visible presentation of the disease. More than half of people with facial acne (52 per cent) also have truncal acne.9 Adult acne tends to affect women more often than men and adult-onset acne is becoming increasingly common in women in their 20s and beyond.10 "Back acne" was once thought to be a predominantly male disease, has been shown to be prevalent in females.7,8,9,11 Acne can trigger feelings of depression, poor body image and low self-esteem.7,10
About AKLIEF® trifarotene cream, 50mcg/g3AKLIEF is a retinoid indicated for the topical treatment of acne vulgaris of the face and/or trunk in patients 12 years of age and older.
The full AKLIEF Cream Product Monograph for Canada is available here.
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 to treat a range of dermatological conditions. Galderma is a leader in the research and development of scientifically-defined and medically-proven solutions for the skin. Partnering with health care practitioners around the world to meet the skin health needs of people throughout their lifetime, the company aims to change the way the world thinks about skin health. For more information, please visit www.galderma.ca.
|1||British Association of Dermatologists. Topical trifarotene: a new retinoid. Br J Dermatol. 2018;179:231-232.|
|2||Data on File, Galderma|
|3||AKLIEF CREAM (trifarotene) Canadian product monograph. https://pdf.hres.ca/dpd_pm/00054047.PDF. Accessed November 28, 2019.|
|4||Drug Bank. Tretinoin, https://www.drugbank.ca/drugs/DB00755. Accessed November 15, 2019.|
|5||Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, et al. Randomized Phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019. DOI: https://doi.org/10.1016/j.jaad.2019.02.044.|
|6||Aubert J, Piwnica D, Bertino B, Blanchet-Réthoré S, Carlavan I, et al. Nonclinical and human pharmacology of potent and selective topical retinoic acid receptor-γ agonist trifarotene. Br J Dermatol. 2018;179:442-456.|
|7||Fisher GJ, et al. J Biol Chem 1994;269(32):20629-35.|
|8||Canadian Dermatology Association. Acne. https://dermatology.ca/public-patients/skin/acne/. Accessed October 28, 2019.|
|9||Del Rosso JQ et al. A closer look at truncal acne vulgaris: prevalence, severity, and clinical significance. J Drugs Dermatol. 2007;6:597–600|
|10||American Academy of Dermatology. Adult acne. https://www.aad.org/public/diseases/acne-and-rosacea/adult-acne. Accessed August 26, 2019|
|11||Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998;139(5):846-850|
SOURCE Galderma Canada