Galderma Achieves FDA Approval of AKLIEF® (trifarotene) Cream, 0.005%
In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. It is the only topical retinoid that selectively targets retinoic acid receptor gamma and is also the first new retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years.
The use of the Simcyp™ PBPK Simulator allowed Galderma to expedite and inform its drug development program, and help provide safety labeling and pediatric dosing information without the need for further testing in clinical patients. Specifically, Simcyp’s Mechanistic Dermal Absorption (MechDermA™) model was used to predict the outcome of specific drug interactions and provide dosing guidance for pediatric patients aged nine to 17. Development of Simcyp’s MechDermA model is the result of a multi-year FDA grant.
We were pleased to partner with Certara to develop this detailed physiologically-based pharmacokinetic (PBPK) model of trifarotene, which provided support for the safety of our drug and additional prescribing information for the drug label. As a leader in modern research and development of scientifically-defined and medically-proven solutions for the skin, we embrace new technologies such as modeling and simulation that improve our effectiveness.
Nathalie WagnerSenior Clinical PK ManagerGalderma, Research & Development, L.L.C.
Acne is the most common skin disease in the United States, affecting up to 50 million Americans annually and approximately 85% of young people. As an inflammatory disease, acne occurs when a combination of sebum and dead skin cells clog pores, allowing the bacteria associated with acne to grow. Acne can trigger feelings of depression, poor body image, and low self-esteem.