As the first agent to be approved for primary biliary cholangitis (PBC), ursodeoxycholic acid (UDCA), which launched nearly two decades ago, transformed the treatment of PBC by greatly reducing mortality rates. Intercept’s novel FXR agonist, obeticholic acid (Ocaliva), was approved in the United States and Europe in 2016 and experienced strong initial uptake, primarily among UDCA nonresponders. However, a black box warning was added to Ocaliva in 2018, and a notable subset of PBC patients are still underserved by UDCA. Given the medical advances in the treatment of other liver disorders, there is renewed interest in the development of new PBC agents to address areas of unmet need. Intercept Pharmaceuticals hopes to capitalize on the need for new PBC agents, specifically for patients who do not respond to UDCA, and pipeline agents have the potential to improve on both UDCA and Ocaliva and thus could gain share in what is poised to become a highly competitive market.
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