Seladelpar Gilead is a medicine used to treat adults with a liver disease known as primary biliary cholangitis. Primary biliary cholangitis is an autoimmune condition in which there is gradual destruction of the bile ducts in the liver. These ducts transport a fluid called bile from the liver to the intestines, where it is used to help digest fats. As a result of the damage to the ducts, bile builds up in the liver, causing damage to liver tissue. This may lead to scarring and liver failure and may increase the risk of liver cancer. Seladelpar Gilead is used together with another medicine, ursodeoxycholic acid (UDCA), in patients for whom UDCA alone does not work well enough, and on its own in patients who cannot take UDCA. Primary biliary cholangitis is rare, and Seladelpar Gilead was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 October 2017. Seladelpar Gilead contains the active substance seladelpar.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
A05AX07
ATC Item
xa 05 ax 07
Pharmacotherapeutic Group
Bile and liver therapy
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| seladelpar lysine dihydrate | N/A | Seladelpar |
| Seladelpar lysine dihydrate | N/A | Seladelpar |
EMA Name
Lyvdelzi (previously Seladelpar Gilead)
Medicine Name
Lyvdelzi (previously Seladelpar Gilead)
Aliases
N/ANo risk management plan link.