What is the name of the drug and what does it do?
Approved on August 19, 2024, Livdelzi (pronounced liv-DEL-zee), generic name seladelpar, is a prescription medicine used to treat adults with primary biliary cholangitis (PBC), a chronic liver disease that damages the bile ducts. It is prescribed for people who do not respond well to the standard treatment, ursodeoxycholic acid (UDCA), or for those who cannot tolerate UDCA.
How does it work?
Livdelzi works by activating a protein in the body called PPAR-delta, which helps reduce bile acid production and inflammation in the liver. This helps protect the liver from further damage and improves bile flow, reducing symptoms of PBC and lowering certain liver test levels.
What did the research discover?
Clinical trials showed that Livdelzi helped reduce a key marker of liver health called alkaline phosphatase (ALP) in people with PBC. In one study, 62% of patients treated with Livdelzi achieved improved liver function compared to only 20% in the placebo group. Patients also experienced a significant reduction in symptoms like itching, a common problem in PBC.
What are some of the side effects?
The most common side effects of Livdelzi include:
- Headache
- Stomach pain or discomfort
- Nausea
- Abdominal swelling
- Dizziness
Serious side effects may include bone fractures and changes in liver function tests. Patients should inform their doctor if they notice unusual symptoms like jaundice (yellowing of the skin or eyes) or severe abdominal pain.
What are the dosage recommendations and how is it prescribed?
The recommended dosage is 10 mg taken orally once daily, with or without food. If the patient also takes medications called bile acid binding resins (to lower cholesterol), Livdelzi should be taken at least 4 hours before or after those medicines. Patients should follow their healthcare provider’s instructions for proper dosing and report any missed doses or side effects.
Source
U.S. Food and Drug Administration. Full prescribing information: [Label for NDA 217899]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf. Accessed 2024 Nov 20.
