Why is Obeticholic acid not sold in the country?

Although obeticholic acid has been approved for primary biliary cholangitis (PBC) in the United States, Europe and Japan, it has not yet been officially launched in mainland China. The main reasons include drug registration and approval requirements and lack of local clinical data. When approving new drugs, China's National Medical Products Administration (NMPA) requires the submission of pharmacokinetic, safety and efficacy data for the Chinese population to ensure the rationality and safety of the drug for local use. Obeticholic acidAs an FXR receptor agonist, its mechanism is novel and its potential side effects are different from traditional bile acid drugs. Therefore, more domestic clinical trial data are needed to support it.

In addition, the price of original research drugs in overseas markets is relatively high, which also affects its domestic launch and medical insurance coverage decisions. China has not yet formed a complete obeticholic acid supply chain and long-term medication management experience, and clinicians and patients may have uncertainties in its use. Some pharmaceutical companies are promoting localized R&D and clinical registration, hoping to provide compliant, safe and sustainable obeticholic acid products in the Chinese market in the future.

In the short term, if domestic patients want to use obeticholic acid, they can only obtain it through overseas medical channels, clinical trials or special imports. However, these channels need to strictly abide by doctor's prescriptions and relevant policies to ensure drug safety. In the long term, with the advancement of domestic drug research and development and local registration, domestic patients are expected to have more treatment options in the future.

In addition, patients and their families need to understand the mechanism of action and clinical effects of obeticholic acid, as well as the potential benefits of combining it with UDCA or other supportive treatments to scientifically manage biliary liver disease. For doctors, being familiar with the application of obeticholic acid in international clinical guidelines in advance can prepare them for future domestic clinical practice.

Reference materials:https://en.wikipedia.org/wiki/Obeticholic_acid