Iqirvo (elafibranor)
OrphanConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- elafibranor
- Company
- Ipsen Pharma
- Status
- Authorised
- Therapeutic area
- Liver Cirrhosis, Biliary
- CHMP opinion
- Thu 25 Jul 2024
- EU approval
- Thu 19 Sep 2024
- Designations
- Orphan, Conditional, Additional monitoring
- Application
- EMEA/H/C/006231
- ATC
- A05AX06
- Official record
- www.ema.europa.eu
Indication
Iqirvo is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.