FDA approves Aklief cream for acne.- Galderma

Galderma announced that the FDA approved Aklief (trifarotene) Cream, 0.005% for the topical treatment of acne. Trifarotene is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years. Aklief Cream 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 acne patients another treatment option. Aklief Cream is expected to be available in the United States in November 2019. It will be provided in a 45 gram pump. Galderma is working closely with payers, providers and pharmacy benefit managers to ensure broad and rapid access to Aklief Cream.

The FDA approval of Aklief Cream is supported by data from the two pivotal Phase III 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 of 2,420 patients 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 (incidence more than 1%) included application site irritation, application site pruritus (itching) and sunburn.

Comment: Aklief Cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.