Lyvdelzi (previously Seladelpar Gilead) (seladelpar lysine dihydrate)
OrphanPRIMEConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- seladelpar lysine dihydrate
- Company
- Gilead Sciences Ireland Unlimited Company
- Status
- Authorised
- Therapeutic area
- Liver Cirrhosis, Biliary
- CHMP opinion
- Thu 12 Dec 2024
- Designations
- Orphan, PRIME, Conditional, Additional monitoring
- Application
- EMEA/H/C/004692
- ATC
- A05AX07
- Official record
- www.ema.europa.eu
Indication
Lyvdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those 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.