Gilead’s Livdelzi wins FDA approval, can challenge Ocaliva dominance in primary biliary cholangitis market

Gilead Sciences has recently announced the US FDA’s approval of seladelpar, its PPAR-δ agonist, under the brand name Livdelzi, for primary biliary cholangitis (PBC). This major turnaround for seladelpar, once a failed non-alcoholic steatohepatitis (NASH) asset, follows Gilead’s acquisition of the asset’s developer, Cymabay Therapeutics, earlier this year. The approval could present a major challenge to Ocaliva (obeticholic acid), which was until recently the sole approved drug for PBC in the US, says GlobalData.

GlobalData’s report, “Primary Biliary Cholangitis Marketed and Pipeline Drugs Assessment, Clinical Trials and Competitive Landscape,” reveals that primary biliary cholangitis is a rare liver disease, with 106,000 total diagnosed prevalent cases in 2022 in the US and over 110,000 expected in 2027.

Jay Patel, Healthcare Analyst at GlobalData, comments, “Though Ocaliva was able to dominate the PBC therapy space for years, 2024 has brought about the rise of two new marketed assets: Ipsen’s PPAR-α/δ agonist Iqirvo (elafibranor), which received conditional approval in June, and now Gilead’s Livdelzi in August. Gilead had previously presented strong Phase III efficacy and safety results for seladelpar at EASL 2024, suggesting it could be a major contender in the PBC market. The approval of Livdelzi vindicates Gilead for its purchase of Cymabay for $4.3 billion in March.”

Gilead is not the only company to have made a major acquisition in PBC in recent months. In September 2023, Alfasigma acquired Intercept Pharma, the developer of Ocaliva, which was then the sole approved drug in PBC in the US and EU. However, just nine months later, the European Medicines Agency (EMA) recommended the revocation of the condition marketing authorisation for Ocaliva in the EU, determining that its risks no longer outweighed its benefits.

Patel concludes, “Ocaliva’s efficacy failure in the EMA’s study will likely mean the end of Ocaliva’s access to the EU market, though this remains subject to the final decision of the European Commission. In addition, its safety was brought into question by the FDA in 2021, which warned US patients of a risk of severe liver injury. Now, Ocaliva is also facing a major competitive threat in the US market from both Iqirvo and Livdelzi. Combined, these challenges could prompt Alfasigma to pivot to other possible indications for obeticholic acid, such as primary sclerosing cholangitis (PSC), where there is a potentially greater market opportunity.”

Edits made by EP News Bureau