New late-breaking data reinforces IQIRVO®’s impact on ALP, fatigue and pruritus in PBC
· Financial Post
About IQIRVO® (elafibranor)
IQIRVO is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist. Activation of PPARα and PPARδ decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. IQIRVO is the first approved PPAR agonist with dual α and δ activation, shown to have complementary anti-inflammatory, anti-cholestatic, anti-fibrotic and metabolic effects. In 2019, IQIRVO was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. IQIRVO was granted U.S. FDA accelerated approval in June 2024, conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA and EMA approvals are contingent on the further verification of clinical benefit. In addition to the U.S., E.U. and UK, IQIRVO is approved in Canada, Australia, Brazil and 13 other countries and is in regulatory processes with other authorities. IQIRVO was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021 and expanded the geographical scope to China, Hong Kong, Taiwan and Macau in March 2026. Read More
IQIRVO is an oral, once-daily, peroxisome proliferator-activated receptor (PPAR) agonist. Activation of PPARα and PPARδ decreases bile toxicity and improves cholestasis by modulating bile acid synthesis, detoxification and transporters. IQIRVO is the first approved PPAR agonist with dual α and δ activation, shown to have complementary anti-inflammatory, anti-cholestatic, anti-fibrotic and metabolic effects. In 2019, IQIRVO was granted Breakthrough Therapy Designation by the U.S Food and Drug Administration (FDA) in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA), the existing first-line therapy for PBC. IQIRVO was granted U.S. FDA accelerated approval in June 2024, conditional approval by the EMA in September 2024 and UK Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA and EMA approvals are contingent on the further verification of clinical benefit. In addition to the U.S., E.U. and UK, IQIRVO is approved in Canada, Australia, Brazil and 13 other countries and is in regulatory processes with other authorities. IQIRVO was developed by GENFIT. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021 and expanded the geographical scope to China, Hong Kong, Taiwan and Macau in March 2026. Read More
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