- In February 2025, Gilead Sciences, Inc. announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar. This treatment is approved for use in combination with ursodeoxycholic acid (UDCA) in adults with primary biliary cholangitis (PBC) who have an insufficient response to UDCA alone, or as a monotherapy for those who cannot tolerate UDCA
- In November 2024, Intercept Pharmaceuticals, Inc., a wholly owned biopharmaceutical subsidiary of Alfasigma S.p.A., announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental New Drug Application (sNDA) for OCALIVA (obeticholic acid, OCA). The sNDA was seeking full approval for the treatment of patients with primary biliary cholangitis (PBC), a rare, progressive disease that predominantly affects women
- In August 2024, Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi (seladelpar) to treat primary biliary cholangitis (PBC). The approval covers its use in combination with ursodeoxycholic acid (UDCA) for adults who have not responded adequately to UDCA, or as a monotherapy for patients who are unable to tolerate UDCA
- In July 2024, Calliditas Therapeutics AB announced that the Phase 2b TRANSFORM trial achieved its primary endpoint, demonstrating a statistically significant reduction in ALP (Alkaline Phosphatase) for both tested doses compared to placebo. The trial assessed setanaxib, a NOX enzyme inhibitor, in patients with primary biliary cholangitis (PBC) and elevated liver stiffness
- In June 2024, Ipsen announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of primary biliary cholangitis (PBC). The approval allows Iqirvo to be used in combination with ursodeoxycholic acid (UDCA) for adults who have had an insufficient response to UDCA, or as a monotherapy for those unable to tolerate UDCA. Iqirvo is now available for prescription to eligible patients in the U.S.
Frequently Asked Questions
The major factors driving the growth of the primary biliary cholangitis therapeutics market are rising prevalence of primary biliary cholangitis (PBC) and advancements in treatment options.
The primary challenges include regulatory challenges and delayed approvals and limited awareness and early diagnosis.
The primary drug segment is expected to dominate the global primary biliary cholangitis therapeutics market, holding a major market share in 2025.
