Is imported obeticholic acid on the market?

Obeticholic acid (Obeticholic acid) is a bile acid analogue and farnesoid X receptor agonist, mainly used to treat primary biliary cholangitis (PBC) in adults with poor clinical efficacy or intolerance to ursodeoxycholic acid (UDCA). Obeticholic acid was first approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2016, and was subsequently approved by the European Medicines Agency (EMA) in December of the same year, under the brand name of Ocaliva. This information shows that obeticholic acid has been widely recognized and used internationally, and its efficacy and safety have been verified by relevant regulatory agencies.

However, for the domestic market, the situation is different for obeticholic acid. According to current information, obeticholic acid has not yet obtained marketing authorization in the country. This means that obeticholic acid cannot be purchased through formal channels in the country. This is undoubtedly a big problem for patients who need to use this drug.

Primary biliary cholangitis is an autoimmune process in which the bile ducts and liver are progressively damaged, leading to fibrosis and cirrhosis. Bile acids increase the risk of damage and fibrosis of damaged bile ducts. Activation of FXR by obeticholic acid reduces bile acid synthesis, inflammation, and resulting liver fibrosis. This may increase survival in patients with primary biliary cholangitis, but to date, the relationship between obeticholic acid and survival in patients with primary biliary cholangitis has not been established.

In addition, for patients, although obeticholic acid is currently not available in China, they can learn about the drug through other channels. At the same time, you can also pay attention to the dynamics of the domestic pharmaceutical market to keep abreast of the domestic launch of obeticholic acid.