Integrated Pharmacokinetic Modeling and Regulatory Writing Support the Approval of a Rare Liver Disease Treatment

Certara scientists and regulatory writers deliver an integrated solution that helps Intercept Pharmaceuticals achieve FDA approval for Ocaliva. Intercept Pharmaceuticals needed to develop a dosing strategy for obeticholic acid (OCA) to treat patients with primary biliary cholangitis (PBC) as well as a regulatory writing strategy for their NDA submission.

Certara scientists used Phoenix NLME to build a physiologic PK model to define the relationship between systemic and hepatic exposure of OCA in PBC patients with and without liver impairment. Certara’s regulatory writing consultancy, Synchrogenix, assembled a team of project managers, writers, and editors to develop the necessary submission documents for the FDA.

Modeling results demonstrated the safety and efficacy of the OCA dosing regimen in PBC patients with and without cirrhosis. The Synchrogenix team prepared all documents required for their new drug application (NDA).

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