Galderma announced that AKLIEF® has completed the European decentralised procedure which will result in approval by all involved European member states
Galderma announced that AKLIEF® (trifarotene 50 mcg/g cream) has concluded its European decentralised procedure resulting in the approval of its summary of product characteristics, package leaflet, and labelling, by all involved European member states. Each of the 16 concerned member states will now issue individual national marketing authorisations for the cutaneous treatment of acne vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and pustules are present. Once approved, trifarotene 50 mcg/g cream will be the first new retinoid molecule launched in the European Union in 25 years.
Although retinoids are the cornerstone of acne treatment, there have been few significant advances or developments in decades, said Professor Thomas Dirschka, University of Witten-Herdecke, Germany. It is encouraging to see innovative approaches to tackling one of the most common and frustrating skin diseases.
“Truncal acne can affect almost half of those with facial acne. It often goes under-reported and underdiagnosed, despite a desire from patients to have it treated,” said Professor Jerry Tan, University of Western Ontario, Windsor, ON, Canada. To date, there has been a lack of scientific evidence on the management of truncal acne and as such, it is important to investigate new treatment options that specifically address this unmet need.
Trifarotene 50 mcg/g cream is the first treatment to selectively target retinoic acid receptor gamma (RAR-γ), the most common RAR found in the skin.2,3,4 Trifarotene 50 mcg/g cream was assessed by regulators on data from two large, randomised Phase III clinical trials (PERFECT 1 & 2).
Acne can severely impact the quality of life and psychological well-being of those who suffer from it. 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 the trunk, said Dr Thibaud Portal, Galderma Global Vice President of Prescription Medicines. This underscores Galderma’s commitment to providing innovative solutions for the most common and frustrating skin diseases.
Source: Business Wire