Iqirvo FDA Approval History
Last updated by Melisa Puckey, BPharm on June 12, 2024.
FDA Approved: Yes (First approved June 10, 2024)
Brand name: Iqirvo
Generic name: elafibranor
Dosage form: Tablets
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Primary Biliary Cholangitis
Iqirvo (elafibranor) is a dual peroxisome-activated receptor (PPAR) alpha/delta (α,δ) agonist used for the treatment of patients with primary biliary cholangitis.
- Iqirvo tablets are used for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) for adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
- Primary biliary cholangitis (PBC) is a rare, progressive, autoimmune cholestatic liver disease that causes a build-up of bile and toxins (cholestasis), and chronic inflammation causes irreversible fibrosis (scarring) of the liver and destruction of the bile ducts. Symptoms include fatigue and itch (pruritus), which can be severely debilitating. Left untreated, PBC can lead to liver failure, or in some cases, death.
- Iqirvo 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.
- Iqirvo is an 80 mg tablet administered orally once daily.
- Iqirvo side effects may include weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash. These side effects affected 5% or more of patients.
- The accelerated approval of Iqirvo is based on data from the Phase III ELATIVE trial.
Development timeline for Iqirvo
Further information
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