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奥贝胆酸上市情况
A farnesoid X receptor agonist, obeticholic acid can inhibit bile acid synthesis and is used to treat primary biliary cirrhosis and non-alcoholic fatty liver disease.
Obeticholic acid marketing status: Obeticholic acid has been marketed in the EU and the United States, but not in China.
1. Obeticholic acid is the first drug approved to treat PBC in the past 20 years. Obeticholic acid received orphan drug designation from the European Medicines Agency's Committee for Orphan Medicines (COMP) in 2010.
2. Obeticholic acid produced by Intercept was first approved by the US FDA on May 27, 2016, and approved by the European Union on December 12, 2016. It is a globally marketed drug for the treatment of primary biliary cirrhosis (PBC).
3. Currently, obeticholic acid is not available in mainland China.
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