Elafibranor FDA Approval Status
Last updated by Judith Stewart, BPharm on Jan 10, 2024.
FDA Approved: No
Generic name: elafibranor
Company: Ipsen
Treatment for: Primary Biliary Cholangitis
Elafibranor is a dual peroxisome activated receptor (PPAR) alpha/delta (α,δ) agonist in development for the treatment of patients with primary biliary cholangitis.
- Primary biliary cholangitis (PBC) is a rare, progressive, autoimmune cholestatic liver disease in which bile ducts in the liver are gradually destroyed. Symptoms include fatigue and pruritus, which can be severely debilitating. Left untreated, PBC can lead to liver failure, or in some cases death.
- Elafibranor works through activation of PPAR α,δ to target multiple cell types and biological processes involved in the pathophysiology of PBC, including cholestasis (impairment of bile flow in the liver), bile toxicity, inflammation and fibrosis and bile acid output.
- In 2019, elafibranor was granted a Breakthrough Therapy Designation by the U.S Food and Drug Administration in adults with PBC who have an inadequate response to ursodeoxycholic acid (UDCA) the existing first-line therapy for PBC.
- The target FDA PDUFA date under priority review is June 10, 2024.
Development timeline for elafibranor
Further information
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