Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis
Shots:
- 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
Ref: Ipsen | Image: Ipsen
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
