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.
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.