FDA OKs Trifarotene, First New Retinol Acne Cream in 20 Years – Medscape

By | October 5, 2019

The US Food and Drug Administration (FDA) has approved trifarotene cream 0.005% (Aklief, Galderma), the first new retinoid molecule to be approved in the United States in over 20 years for the once-daily topical treatment of acne vulgaris, according to a company news release.

Trifarotene is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin. It’s also the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose, and chin) and truncal (chest, shoulders, and back) acne, the company said in a news release. It is approved for patients aged 9 years or older.

“While retinoids are foundational therapies to treat acne, there has been little innovation in decades,” Sandra Johnson, MD, FAAD, an investigator in the trifarotene clinical trials and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas, said in the release.

Aklief cream is a “unique, highly-targeted retinoid that reduces inflammatory lesions on the face, back, chest and shoulders, that has also been shown to be safe and well-tolerated,” she added.

Trifarotene cream applied once daily was assessed in two identical, 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled, phase 3 clinical trials involving 2420 patients with moderate acne on the face and trunk.

In both trials, trifarotene cream significantly reduced inflammatory lesions as early as 2 weeks on the face and 4 weeks on the back, shoulders, and chest compared with vehicle (P < .05), the company said.

Trifarotene cream was well tolerated when used on the face, back, shoulders, and chest. The most common adverse reactions (incidence > 1%) included application-site irritation, application-site pruritus, and sunburn.

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The product safety information states that patients may experience erythema, scaling, dryness, and stinging/burning. It advises using a moisturizer from the initiation of treatment and, depending upon the severity of these adverse reactions, reducing the frequency of application, or suspending or discontinuing use.

Trifarotene cream is expected to be available in the United States in November 2019. It will be provided in a 45-gram pump. Galderma said it is working with payers, providers, and pharmacy benefit managers to ensure access to the cream. The company will also offer a patient savings card program called Galderma CareConnect.

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