Why is Obeticholic acid not sold in China?

In 2018, the U.S. Food and Drug Administration issued a black box warning against the use of obeticholic acid because it can worsen liver function in patients with advanced liver disease and cirrhosis. Additionally, studies have found that in patients with primary cholangitis (PBC) and decompensated cirrhosis, administration of higher than normal levels of obeticholic acid fatally exacerbates liver decompensation and failure. Therefore, obeticholic acid may not have passed the relevant domestic regulations and has not been put on the market yet.

Obeticholic acid is a relatively new pharmaceutical agent used in sick populations for which few available pharmacological treatments exist. Current FDA guidance approves obeticholic acid for use in patients with PBC who have failed treatment or are intolerant to ursodeoxycholic acid (UDCA). The FDA recommends routine monitoring of patients receiving obeticholic acid through laboratory and clinical evaluation to determine if dose adjustment is needed. Patients who progress fromChild-Pugh class A to class B or C require dose reduction. Close monitoring of patients at increased risk for hepatic decompensation is also recommended, including but not limited to patients with worsening of liver function tests and coagulation tests (e.g., INR).

Since the original drug of obeticholic acid has not yet been marketed in the country, it cannot be 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.