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First New Retinoid Molecule Approved in Over 20 Years
/CNW/ - Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that Health Canada approved AKLIEF® trifarotene...
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 Ph.D., 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.
