Is Obeticholic acid on the market?

Obeticholic acid is a farnesoid-X receptor (FXR) agonist used to treat this disease and may help improve survival rates. 1 In 2016, it was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of primary cholangitis in combination with ursodeoxycholic acid (UDCA), previously the main treatment for this disease. In May 2021, the FDA updated its prescribing information to prohibit the use of chenodeoxycholic acid in patients with primary cholangitis and advanced cirrhosis (such as portal hypertension or hepatic decompensation).

Primary cholangitis, which may also be called primary biliary cirrhosis, is an autoimmune process in which the bile ducts and liver are gradually damaged, leading to fibrosis and cirrhosis. Bile acids increase the risk of damage and fibrosis of damaged bile ducts. Obeticholic acid can be used to regulate the hepatic metabolism of bile and cholesterol, acting by binding to the farnes X receptor (FXR) found in the nuclei of liver and intestinal cells, thereby increasing hepatic bile flow, inhibiting its production and reducing the exposure of hepatocytes to excess bile in cholestasis.

The original drug of obeticholic acid has not yet been marketed in the country, so it has not been included in medical insurance. The original obeticholic acid drug marketed overseas is expensive, with each box costing around tens of thousands of yuan. The price is also affected by exchange rates and is unstable. It is understood that obeticholic acid has been produced as a generic drug and its ingredients are basically the same as those of the original drug. For example, the price of 5mg*30 tablets produced by a Bangladesh pharmaceutical factory is around RMB 1,000 per box (the price may fluctuate due to the exchange rate), and the price is cheap. For more drug information and specific prices, please consult a medical consultant.