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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

United kingdomUnited statesIpsen iqirvoKris kowdleyIpsen genfitRobert stottChristelle huguetIpsen pharma iqirvoEuropean medicines agencyRegulatory agencyLiver instituteIpsen pharmaLiver institute northwestUnited kingdom medicines

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.

United kingdomUnited statesKris kowdleyChristelle huguetIpsen iqirvoLiver instituteHealthcare products regulatory authorityDrug administrationEuropean medicines agencyAmerican associationLiver diseaseLiver institute northwestEuropean associationUnited kingdom medicinesHealthcare products regulatoryBreakthrough therapy designation

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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United statesUnited kingdomFrance generalHong kongPascal prigentIpsen euronextIpsen iqirvoStephanie boyerExchange commissionEuropean medicines agencyDrug administrationRegulatory agencyNewborn developmentTerns pharmaceuticalsIpsen pharmaceuticalsIpsen pharmaceuticals inc

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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United statesHong kongUnited kingdomFrance generalChristelle huguetIpsen iqirvoCarol robertsKris kowdleyLiver instituteEuropean medicines agencyAgency sourceIpsen pharmaceuticalsDrug administrationRegulatory agencyNewborn developmentIpsen pharmaceuticals inc

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

Hong kongUnited statesFrance generalUnited kingdomChristelle huguetKris kowdleyCarol robertsIpsen iqirvoHead of researchIpsen pharmaceuticals incNewborn developmentRegulatory agencyLiver instituteAgency sourceIpsen pharmaceuticalsEuropean medicines agency