What kind of medicine is obeticholic acid tablets and what are its indications?

Obeticholic acid is a synthetically modified bile acid and a potent agonist of farnesolide X nuclear receptor (FXR), which plays a major role in the synthesis and transport of bile acids, lipid metabolism, and glucose homeostasis. Obeticholic acid has been shown to improve serum enzymes in several diseases, including nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC, formerly known as primary biliary cirrhosis). Obeticholic acid was approved in the United States in 2016 for the treatment of primary biliary cholangitis and is currently being evaluated in other liver diseases, including primary sclerosing cholangitis (PSC) and nonalcoholic steatohepatitis (NASH).

Primary biliary cholangitis is a chronic liver disease that primarily affects the biliary system. This disease causes cholestasis in the liver and triggers inflammation and fibrosis. If left untreated, the diseasemay progressively worsen and lead to liver failure. Obeticholic acid has important indications in the treatment of PBC, and the main scenarios include the following situations: without cirrhosis; or for compensated cirrhosis without evidence of portal hypertension. Obeeticholic acid is approved under accelerated approval for use either in combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA or as monotherapy in patients who cannot tolerate UDCA.

Obeeticholic acid is available in 5 mg and 10 mg tablets under the brand name Ocaliva. The typical initial dose for primary cholangitis is 5 mg once daily, which may be increased to a maximum of 10 mg daily. Side effects include itching, fatigue, nausea, and headache. Itching symptoms appear to decrease if treatment is started at a low dose and gradually increased. Less common but potentially serious adverse reactions include allergic reactions and depression.