Case Study: Galderma achieves FDA approval for AKLIEF with Certara's Simcyp PBPK Simulator

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

Galderma, a pharmaceutical company focused on dermatology, sought to achieve FDA approval for its new acne treatment, AKLIEF® Cream. Their challenge was to provide comprehensive safety labeling and pediatric dosing information for the drug without conducting additional, lengthy clinical trials on patients. To address this, Galderma partnered with Certara and utilized its Simcyp™ PBPK Simulator.

Certara's solution involved using the Simcyp Simulator's Mechanistic Dermal Absorption (MechDermA™) model. This model predicted drug interactions and provided crucial dosing guidance for pediatric patients. As a result, Galderma successfully obtained FDA approval for AKLIEF®, the first new retinoid molecule for acne in over 20 years. The use of Certara's technology expedited the development program and eliminated the need for further clinical testing in the target patient population.

Galderma

Nathalie Wagner

Senior Clinical PK Manager