Case Study: Novartis streamlines asciminib NDA submission with Certara's PBPK modeling

Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials

The customer, Asciminib, a novel drug from Novartis, faced the traditional challenge of needing extensive clinical trials to establish multiple dosing regimens and assess drug-drug interactions, food effects, and safety in specific patient populations. This process is typically time-consuming and costly. The vendor, Certara, addressed this challenge by applying its Simcyp PBPK Simulator to implement a model-informed drug development (MIDD) strategy.

Certara's solution utilized physiologically-based pharmacokinetic (PBPK) modeling to bridge data between dosing regimens and generate regulatory-ready predictions. This approach replaced the need for over 10 traditional clinical pharmacology studies. The results were significant: the FDA approved the 80 mg and 200 mg dosing regimens based on this PBPK data, which dramatically streamlined the development process, reduced costs, and helped bring the drug to market faster.

Asciminib