Pharmacokinetic Modeling Supports the Approval of a Rare Liver Disease Treatment

Primary biliary cholangitis (PBC) is a chronic, rare disease characterized by cholestasis—the impaired flow of bile from the liver.1 The resulting increased bile acid concentrations cause cellular injury. Untreated PBC can lead to liver failure and death. The only currently approved treatment for PBC was ursodeoxycholic acid (UDCA). However, not all patients respond to UDCA. Intercept Pharmaceuticals—an emerging global biopharmaceutical company—sought to develop obeticholic acid (OCA) as an alternative treatment for PBC. OCA is a semi-synthetic analogue of the primary bile acid chenodeoxycholic acid with similar pharmacokinetic (PK) properties.2 Like other bile salts, OCA is metabolized via conjugation to glycine acid and taurine. OCA is a selective and potent farnesoid X receptor (FXR) agonist.2 FXR activation decreases the concentration of bile acids in the liver to reduce cellular injury. FGF-19 was used as a biomarker for OCA pharmacological activity.

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TAAG Genetics

TAAG Genetics is a molecular diagnostic research company that develops, manufactures and distributes its products and services of genetic analysis to individuals and companies in the clinical and industrial areas. The diagnostic solutions delivered by TAAG Genetics, focus on the applications that multiplex PCR-based exams can have for our clients, such as the screening of multiple pathogens in medical institutions, food companies, agricultural and environmental areas.

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TAAG Genetics

TAAG Genetics is a molecular diagnostic research company that develops, manufactures and distributes its products and services of genetic analysis to individuals and companies in the clinical and industrial areas. The diagnostic solutions delivered by TAAG Genetics, focus on the applications that multiplex PCR-based exams can have for our clients, such as the screening of multiple pathogens in medical institutions, food companies, agricultural and environmental areas.

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