Obetix(奥贝胆酸)是什么时候上市的,Obetix(Obeticholic acid)在2016年5月27日获美国FDA批准上市。随后，2016年12月12日奥贝胆酸(Obeticholicacid)在获欧盟批准上市。目前奥贝胆酸(Obeticholicacid)原研药并未在中国上市。

Obeticholic Acid (Obetix) is a medication approved for the treatment of primary biliary cholangitis (PBC). It was first approved by the United States Food and Drug Administration (FDA) on May 27, 2016. Since then, it has been approved in several other countries, including the European Union, Canada, and others, making it accessible to patients worldwide. Obetix offers hope to individuals suffering from this chronic liver disease, providing an effective treatment option to improve their quality of life. In this article, we will explore the timeline and key milestones in the approval and launch of Obetix.

1. Development and Clinical Trials

The development of Obetix began with preclinical research and extensive clinical trials to evaluate its safety and efficacy. The drug underwent rigorous testing to ensure its benefits outweighed any potential risks. Clinical trials involved participants with primary biliary cholangitis, and the data collected from these trials provided critical evidence to support the drug's approval.

2. FDA Approval in the United States

On May 27, 2016, the FDA granted accelerated approval to Obeticholic Acid (Obetix) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA or as monotherapy in adults who are unable to tolerate UDCA. The approval of Obetix offered new hope for patients who had limited treatment options available.

3. Global Expansion and Approvals

Following the FDA approval, Obetix received approval in the European Union by the European Medicines Agency (EMA) in December 2016. The EMA authorized the use of Obetix for the treatment of primary biliary cholangitis (PBC) in combination with UDCA in adult patients with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA. The authorization in the European Union expanded the availability of Obetix to patients across Europe.

Additionally, Obetix obtained approval in Canada from Health Canada in 2017, further broadening its availability and accessibility. The drug's approval in multiple jurisdictions reflects its potential clinical benefits and the recognition of its role in treating patients with primary biliary cholangitis.

4. Continued Research and Accessibility

Following the initial approvals, ongoing research and real-world data collection have played a crucial role in enhancing our understanding of Obetix's effectiveness, safety, and long-term outcomes. The continued research aims to provide healthcare professionals and patients with further insights into the optimal use of Obetix to maximize its therapeutic benefits.

In terms of accessibility, efforts have been made to ensure that Obetix is available to individuals who can benefit from it. These efforts include working with healthcare systems, insurance companies, and patient assistance programs to facilitate access and affordability for patients prescribed Obetix.

In conclusion, Obetix, also known as Obeticholic Acid, was first approved for the treatment of primary biliary cholangitis in the United States in May 2016. Since then, it has received approvals in various countries, allowing patients worldwide to benefit from this medication. The development, clinical trials, and subsequent approvals of Obetix represent an important milestone in the field of hepatology and provide hope for patients living with primary biliary cholangitis. Ongoing research and efforts to improve accessibility further contribute to the positive impact of this medication in the lives of those affected by this chronic liver disease.