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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 Kingdom , United States , Ipsen Iqirvo , Kris Kowdley , Ipsen Genfit , Robert Stott , Christelle Huguet , Ipsen Pharma Iqirvo , European Medicines Agency , Regulatory Agency , Liver Institute , Ipsen Pharma , Liver Institute Northwest , United 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. ....

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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
newswiretoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from newswiretoday.com Daily Mail and Mail on Sunday newspapers.

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Ipsen's Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis | Company Announcement

Ipsen's Iqirvo® receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis | Company Announcement
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