Galderma Acne treatment receives approval from Europe
Galderma’s acne cream AKLIEF (trifarotene 50 mcg) has received approval by the European Union after reviewing its summary of product characteristics, package leaflet and labelling.
Each of the 16 European nations involved will now issue individual marketing authorisations for the treatment of acne vulgaris for patients 12 years or older.
The cream is the first treatment to selectively target retinoic acid receptor gamma (RAR-g), the most common RAR found in the skin.
Dr Thibaud Portal, Galderma’s Global Vice President of Prescription Medicines, said: “The approval of AKLIEF will provide patients across Europe with a next-generation retinoid cream that has been shown to be fast and effective at treating acne on both the face and body.”
Trifarotene 50 mcg/g cream was assessed by regulators on data from two large Phase 3 clinical trials. The cream has been shown to reduce inflammatory lesions as early as two weeks on the face, and four weeks on the back and shoulders.
Thomas Dirschka, Professor at the University of Witten-Herdecke, said: “Although retinoids are the cornerstone of acne treatment, there have been few significant advances or developments in decades. It is encouraging to see innovative approaches to tackling one of the most common and frustrating skin diseases.”
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