Latest News on Obeticholic Acid

Obeticholic acid (Obeticholic acid) is used to treat primary cholangitis (PBC) in adults who have not developed cirrhosis, sometimes along with another drug called ursodeoxycholic acid (UDCA ). Primary cholangitis is a chronic liver disease that can damage the bile ducts in the liver and may lead to cirrhosis (scarring of the liver) and liver failure. PBC is a progressive disease and there may be no symptoms for many years.

Primary biliary cholangitisManagement of patients with primary biliary cholangitis (formerly known as primary biliary cirrhosis) who do not have cirrhosis or compensated cirrhosis and no evidence of portal hypertension (FDA designated orphan drug for this condition). Obeticholic acid will be used in combination with ursodeoxycholic acid in patients who have failed to respond to ursodeoxycholic acid therapy, or alone in patients who are intolerant to ursodeoxycholic acid. Obeticholic acid has received accelerated approval based on lowering alkaline phosphatase concentrations, but clinical benefits (such as improvement in disease-related symptoms, improvement in survival) have not been proven. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

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.