Galderma's AKLIEF (Trifarotene) Cream Receives FDA Approval as First-in-Class Topical Retinoid for Acne Treatment

On October 9, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that the Swiss pharmaceutical company Galderma announced that its AKLIEF (trifarotene) cream had received FDA approval for marketing, indicated for the topical treatment of acne. This medication provides a new therapeutic option for patients with facial acne.

Acne is a chronic inflammatory skin disease commonly seen in adolescents, caused by the clogging of pores with a combination of sebum and dead skin cells. Patients often present with visible symptoms on the face, including comedones, papules, pustules, and nodules. More than half of patients with facial acne suffer from truncal acne. It is reported that acne has a greater impact on women, with a higher incidence rate among women over the age of 20, and lesions frequently appear on the back.

Galderma, founded in 1981 and headquartered in Lausanne, Switzerland, is the world’s largest independent dermatology company. As a leader in dermatological solutions, the company is dedicated to developing novel therapeutic agents to meet the healthcare needs of patients with skin conditions worldwide. Currently, Galderma’s dermatological treatments are exported to more than 100 countries and regions.

AKLIEF is the first FDA-approved topical retinoid for the treatment of acne. Retinoids selectively target RARγ, the most prevalent retinoic acid receptor in skin tissue. Clinical trials have demonstrated that AKLIEF provides effective and well-tolerated topical treatment for acne on the forehead, cheeks, nose, chest, shoulders, and back.

AKLIEF cream is indicated for patients aged 9 years and older with acne vulgaris. Common adverse reactions include pruritus at the application site; severe cases may present with erythema, desquamation, dry skin, and stinging. Galderma stated that patients using AKLIEF cream should avoid exposing the treated areas to light sources such as sunlight and fluorescent lamps, or take protective measures, such as wearing sun-protective clothing and applying sunscreen to the affected areas.

“Retinoids are among the cornerstone agents in the treatment of acne, yet there have been virtually no innovative drugs based on this class for decades,” said Dr. Sandra Johnson, a dermatologist and investigator in the AKLIEF clinical trials. “I am pleased that AKLIEF cream has received FDA approval for marketing, providing patients with a safe, well-tolerated, and highly targeted therapy to reduce inflammatory lesions on the face, back, chest, and shoulders.”

Dr. Thibaud Portal, Vice President of Galderma, stated, “Galderma is committed to bringing novel active molecules to market, providing new treatment options for patients with dermatological conditions. We are pleased to launch AKLIEF cream, a novel acne therapy, in the United States. Multiple clinical trials have demonstrated its efficacy in treating facial and truncal acne.”

(Compiled by Xu Xiaoxue)