Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

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.

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.