Obeticholic Acid – From PK Model to Drug Label

Speaker(s): Jeffrey Edwards
Date: June 1, 2017
Time: 11 am ET
Duration: 1 hr.

Obeticholic acid (OCA) is a selective and potent farnesoid X receptor (FXR) agonist in development for the treatment of primary biliary cholangitis/cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), and other liver diseases. OCA is the 6α-ethyl derivative of chenodeoxycholic acid (CDCA) and has similar pharmacokinetic (PK) properties.

The results from a hepatic impairment clinical study revealed that systemic OCA concentrations increased with moderate and severe hepatic impairment. These results are consistent with previously reported studies wherein plasma endogenous bile acids were elevated in patients with hepatic impairment, but liver concentrations were only modestly increased. Accordingly, an alternate dosing regimen was developed for OCA based on modeling and simulations for patients with moderate and severe hepatic impairment to mitigate tolerability concerns with high systemic exposures.

Join this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to understand the relationship between systemic and hepatic exposure of OCA in patients with and without hepatic impairment. By attending this webinar, you will learn how pharmacokinetic modeling can support optimal dosing for patients with organ impairment and facilitate regulatory approval.

About Our Speaker

Dr. Jeffrey E. Edwards has over ten years of industrial experience in clinical and preclinical pharmacokinetics and pharmacology. He received a BS in Chemistry from James Madison University and then earned his Doctorate in Toxicology at University of Kentucky in the lab of Patrick J. McNamara. After completing his post-doctoral work at North Carolina State University, Dr. Edwards began his industrial career in pharmacokinetics and pharmacology at Arena Pharmaceuticals, Inc. followed by Amylin Pharmaceuticals, LLC. Most recently, Dr. Edwards serves as the Senior Director of Clinical and Preclinical Pharmacology and DMPK at Intercept Pharmaceuticals, Inc.

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