FDA Approves New Topical Cream to Treat Acne

For the first time in 2 decades, the US Food and Drug Administration (FDA) has approved a retinoid molecule to treat acne called AKLIEF Cream.

The FDA gave the approval to Galderma for the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.

AKLIEF Cream is the first topical treatment specifically studied and proven to treat both facial and truncal acne, offering healthcare professionals and acne patients another treatment option.

“While retinoids are foundational therapies to treat acne, there has been little innovation in decades,” Sandra Johnson, MD, an investigator in the clinical trials of AKLIEF Cream and a dermatologist at Johnson Dermatology in Fort Smith, Arkansas, said in a statement. “With the approval of AKLIEF Cream, I am excited to offer my patients 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.”

The basis for the approval is data from a pair of phase III clinical trials of once-daily AKLIEF Cream in patients with moderate acne on the face and trunk.

The 2 identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2420 patients showed that AKLIEF Cream significantly reduced inflammatory lesions as early as 2 weeks on the face and 4 weeks on the back, shoulders and chest compared to vehicle (P <.05).

The investigators found that the cream was well tolerated when used on the face, back, shoulders, and chest, with the most common adverse reactions being application site irritation, application site itching, and sunburn.

“The approval of AKLIEF Cream underscores our ability to bring new active molecules to the community, and innovate even in well-established therapeutic classes,” Thibaud Portal PhD, Galderma Global Vice President, Prescription, said in a statement. “It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne.”

Galderma is expected to make the cream available in the US in November with a 45-gram pump.