The past few months have ushered in a new era of treatment for patients suffering from primary biliary cholangitis (PBC), marked by the approval of Ipsen’s Iqirvo (elafibranor) on June 10th, 2024, followed by Gilead’s Levdelzi (seladelpar) on August 14th, 2024. Both treatments are oral peroxisome proliferator-activated receptor (PPAR) therapies, representing the first major advancements in PBC treatment in nearly a decade. These new assets were approved for use in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients who cannot tolerate UDCA.

One month prior to Iqirvo’s approval, Spherix Global Insights surveyed 103 US gastroenterologists and liver specialists to gauge their perceptions on the PBC pipeline and intent to prescribe these assets once approved. At that time, participating specialists showed a clear preference for Livdelzi over Iqirvo, with nearly half selecting the Gilead brand as their preferred PBC treatment in development, compared to less than one-third favoring Ipsen’s asset. Preference for Livdelzi was attributed to the product’s efficacy data and the treatment of pruritus, a chronic itch that many PBC patients experience. As one physician indicated, “It [Livdelzi] seems to meet its primary endpoint the highest out of all 4 drugs with the least amount of adverse events. Also shows some improvement in helping with itching [pruritus].”

As part of the Launch Dynamix™ service, Spherix will be closely tracking the uptake of both Iqirvo and Livdelzi over the first eighteen months of their availability. In the initial pulse tracking for Iqirvo (August 2024), approximately three-quarters of participating specialists reported being aware of its approval, with the brand recognized as a significant advancement over existing PBC treatment options. Moreover, just one-month post-launch, half of the respondents indicated current or anticipated trial of Iqirvo within the next three months.

While Iqirvo has shown strong successful launch indicators early out of the gate, the evolving competitive landscape with the introduction of Livdelzi will likely influence future perceptions and adoption. Spherix will continue to monitor both product launches, assessing the competitive dynamics and their implications for overall treatment strategies as part of the comprehensive Launch Dynamix™ service.

Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.

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NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release.

Jim Hickey, Gastroenterology Franchise Head
Spherix Global Insights
4848794284
james.hickey@spherixglobalinsights.com