Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis


The US FDA has granted accelerated approval to Iqirvo (80mg tablets) in addition to ursodeoxycholic acid (UDCA) to treat PBC adults having inadequate response to UDCA or as monotx. in UDCA intolerant patients. Full approval depends on (ELFIDENCE) confirmatory trial
The approval was based on a P-III (ELATIVE) study assessing the safety & efficacy of Iqirvo (80mg, QD) + UDCA (n=108) vs PBO + UDCA (n=53) to treat PBC. Results, published in the NEJM, showed BCR in 51% vs 4% of patients with a 47% treatment benefit & ALP normalization at wk.52 in 15% vs 0% of them, sustained through wk.52 & evident by wk.4
In addition, the company has submitted Iqirvo for PBC to the EMA & MHRA with the decisions expected in H2’24

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