Officials from the FDA have approved Galderma’s trifarotene cream, 0.005% (Aklief) for the topical treatment of acne.

Trifarotene is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin, according to the company. The cream is also the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose, and chin) and truncal (chest, shoulders, and back).

Sandra Johnson, MD, FAAD, an investigator in the clinical trials of Galderma’s trifarotene cream and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas, said she feels that trifarotene will be very beneficial to the acne community.

“This approval marks a significant step forward in the innovation of retinoids, as trifarotene is highly selective,” she said in a prepared statement. “Additionally, the selectivity of trifarotene for retinoic acid receptor gamma distinguishes it from the existing first- and third-generation topical retinoids, which target both retinoic acid receptors beta and gamma; in turn, this may help reduce the risk of side effects mediated by the other receptors.”

The approval is supported by data from a pair of Phase 3 clinical trials of Galderma’s once-daily trifarotene cream in patients with moderate acne on the face and trunk. The study had 2420 patients who were a part of 2 identical 12-week clinical trials. The trifarotene cream showed a significant reduction in inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders, and chest. The most common adverse reactions included application site irritation, application site pruritus (itching), and sunburn.

Trifarotene is the first new retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years. The cream is expected to be available in the United States in November 2019 as a 45-gram pump.


Reference

Galderma receives FDA approval for Aklief (trifarotene) cream, 0.005%, the first new retinoid molecule for the treatment of acne in over 20 years [news release]. Fort Worth, Texas; Galderma Newsroom: October 4, 2019. https://www.multivu.com/players/English/8613051-galderma-aklief-retinoid-molecule-acne-treatment/. Accessed October 7, 2019.