Galderma announced the FDA has approved Aklief (trifarotene) Cream, 0.005% for the topical treatment of acne. Aklief Cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. Aklief is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.
The FDA approval was based on data from two pivotal Phase 3 clinical trials of once-daily Aklief Cream in patients with moderate acne on the face and trunk. The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials enrolled 2,420 patients. Results showed that Aklief Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle. Aklief Cream was well tolerated when used on the face, back, shoulders and chest. The most common adverse reactions included application site irritation, application site pruritus and sunburn.