Galderma has launched a cream containing the first retinoid to receive FDA approval for the treatment of acne in more than 20 years.
Announcing the FDA’s approval of its Aklief (trifarotene) Cream, 0.005%, Galderma said it is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.
According to Galderma global vice president of prescription products, Thibaud Portal, the 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”.
“The approval of Aklief Cream underscores our ability to bring new active molecules to the community, and innovate even in well-established therapeutic classes,” he said.
“It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated.”
The FDA approval is supported by two Phase 3 clinical trials of once-daily Aklief Cream in patients with moderate acne on the face and trunk.
According to Galderma, the “two identical 12-week, randomised, multicentre, parallel group, double-blind, vehicle-controlled clinical trials of 2420 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”.
In addition, the cream was well tolerated when used on the face, back, shoulders and chest with the most common adverse reactions including application site irritation, application site pruritus (itching) and sunburn.
Aklief Cream is expected to be available in the US next month.
The company is working closely with “payers, providers and pharmacy benefit managers to ensure broad and rapid access to Aklief Cream” as “acne is the most common skin disease in the US” which affects up to 50 million people a year.
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