Case Study: Pharmacyclics achieves FDA-recognized DDI dosing guidance with Certara's Simcyp Simulator

DDI Regulatory Poster Child using the Simcyp Simulator Ibrutinib (Imbruvica®)

The customer, Pharmacylics, along with its partner J&J, sought to bring its oncology drug ibrutinib to market but faced challenges with potential drug-drug interactions and the need for a dose optimization strategy. They worked with the vendor Certara, leveraging its Simcyp Simulator and PBPK Modeling Services to address these issues.

Certara used its Simcyp Simulator to build and validate PBPK models, which predicted the effects of various CYP3A4 inhibitors and inducers on ibrutinib exposure. This solution allowed the drug label to include 24 claims for untested DDI scenarios without the need for additional clinical trials and provided a critical dose optimization strategy. The successful regulatory outcome established a best practice, and the drug, Imbruvica®, has since been approved for 11 indications and has treated nearly 200,000 patients globally.

Pharmacylics