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FDA approves Ipsen's Iqirvo 'to address unmet need' in primary biliary cholangitis

The FDA granted accelerated approval to Ipsen Pharma’s Iqirvo 80 mg, a first-in-class oral, once-daily peroxisome proliferator-activated receptor agonist for the treatment of primary biliary cholangitis, according to a company release. Originally given breakthrough therapy designation in 2019, Iqirvo (elafibranor, Ipsen/Genfit), is now indicated as second-line therapy in combination with

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FDA Grants Accelerated Approval to Elafibranor (Iqirvo) for PBC

The accelerated approval is based on data from the phase 3 ELATIVE trial demonstrating a reduction in alkaline phosphatase with elafibranor.

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GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo® for Primary Biliary Cholangitis | 10.06.24

GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo® for Primary Biliary Cholangitis | 10.06.24
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Newswire & Press Release / Ipsen's Iqirvo® Receives U.S. FDA Accelerated Approval as A First-in-class PPAR Treatment for Primary Biliary... - Pharma / BioTech / Nutrition - IPSEN Group

Newswire & Press Release / Ipsen's Iqirvo® Receives U.S. FDA Accelerated Approval as A First-in-class PPAR Treatment for Primary Biliary... - Pharma / BioTech / Nutrition - IPSEN Group
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Newswire & Press Release / Ipsen's Iqirvo® Receives U.S. FDA Accelerated Approval as A First-in-class PPAR Treatment for Primary Biliary... - Pharma / BioTech / Nutrition - IPSEN Group

Newswire & Press Release / Ipsen's Iqirvo® Receives U.S. FDA Accelerated Approval as A First-in-class PPAR Treatment for Primary Biliary... - Pharma / BioTech / Nutrition - IPSEN Group
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