New FDA Approval: LIVDELZI® (seladelpar)
The U.S Food and Drug Administration (FDA) recently approved Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The use of Livdelzi is not recommended for people who have or develop decompensated cirrhosis.
Read InpharmD's summary below:
| Drug Name |
LIVDELZI® (seladelpar) |
| Active Ingredient |
seladelpar |
| Date of Approval |
August 14, 2024 |
| Manufacturer |
Gilead Sciences, Inc. |
| Approval Pathways and Indications |
Approval Pathway: Accelerated Approval
Indication: LIVDELZI® 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, or as monotherapy in patients unable to tolerate UDCA. |
| Therapeutic Class |
a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist |
| Formulation |
10 mg capsules |
| MoA |
LIVDELZI® is a PPARδ agonist that works in the treatment of PBC by regulating critical metabolic and liver disease pathways involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage, and transport. |
| Dosing and Administration |
The recommended dosage of LIVDELZI® is 10 mg orally once daily with or without food. |
| Administered by self or by HCP |
Administered by self |
| Place in Therapy |
Primary biliary cholangitis (PBC) is a rare autoimmune disease affecting about 130,000 Americans, mainly women. It can lead to liver damage and failure if untreated, with no current cure.
LIVDELZI® is the first treatment to significantly reduce biochemical response, ALP levels, and pruritus compared to placebo, addressing the unmet needs of PBC patients. It offers an alternative for those who don't respond well to current treatments, which leaves them at risk of further liver damage. LIVDELZI® has shown sustained efficacy and safety, including the potential to normalize ALP in some cases.
Approved under accelerated approval for ALP reduction, further confirmation is needed for continued approval. LIVDELZI® is not recommended for patients with decompensated cirrhosis. |
| Expected Market Launch Date |
Data Unavailable |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
$12,606 per 30 days of therapy |
| Product Discontinuation |
N/A |
| Clinical Trials |
The accelerated approval of LIVDELZI® was primarily based on results from the Phase 3 RESPONSE study, a placebo-controlled trial. The study demonstrated that 62% of participants taking LIVDELZI® achieved the primary endpoint of a composite biochemical response at 12 months, compared to 20% in the placebo group. LIVDELZI® also led to normalization of ALP levels, a marker of cholestasis and liver disease risk, in 25% of participants, whereas no placebo recipients experienced this improvement. Additionally, LIVDELZI® significantly reduced pruritus by month 6, a key secondary endpoint. The treatment showed durable improvements in both pruritus and cholestasis markers. The most common adverse events in the LIVDELZI® group included headache, abdominal pain, nausea, abdominal distension, and dizziness, but there were no serious adverse events related to the treatment. LIVDELZI® is notable for its effectiveness in improving both pruritus and cholestasis markers in patients with PBC. |
| Sources |
U.S. Food and Drug Administration. Livdelzi (seladelpar)
[package insert]. Updated August 2024. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217899s000lbl.pdf
Gilead Sciences, Inc. Gilead’s Livdelzi (seladelpar) granted accelerated approval for primary biliary cholangitis by US FDA. Gilead Sciences website. August 2024. Available from: https://www.gilead.com
/news-and-press/press-room/press-releases/2024/8/gileads-livdelzi-
seladelpar-granted-accelerated-approval-for-primary-biliary-cholangitis-by-us-fda
Drugs.com. Livdelzi (seladelpar) history. Drugs.com website. Available from: https://www.drugs.com/history/livdelzi.html
Reuters. US FDA approves Gilead’s liver disease drug. Reuters. August 14, 2024. Available from: https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-gileads-liver-disease-drug-2024-08-14/#:~:t
ext=Livdelzi's%20list%20price%
20is%20%2412%2C606%20per%2030%20days%20of%20therapy |
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