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.

QUESTIONS ANSWERED

  • How effective are the current therapies, UDCA and Intercept Pharmaceuticals’ Ocaliva, in treating PBC?
  • Given the black box warning it received in 2018, how has the market outlook for Ocaliva in PBC patients changed in the United States and the EU5?
  • With the availability of UDCA and Ocaliva, what areas of unmet need remain in the treatment of PBC? What improvements can emerging agents offer in the management of PBC?
  • What clinical endpoints do emerging agents need to meet in order to compete effectively against UDCA and Ocaliva?

CONTENT HIGHLIGHTS

  • Geographies: United States and EU5.
  • Primary Research: Six country-specific interviews with thought-leading hepatologists/ gastroenterologistssupported by survey data collected for this study.
  • Epidemiology: Diagnosed prevalence of primary biliary cholangitis by country, drug-treated cases of primary biliary cholangitis by country.
  • Forecast: Drug-level sales and patient share of key primary biliary cholangitis therapies in 2018 and 2028.
  • Emerging Therapies: Phase II: 10 drugs.

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