Chemistry:Elafibranor

From HandWiki

Elafibranor, sold under the brand name Iqirvo, is a medication used for the treatment of primary biliary cholangitis.[1][2]

Elafibranor is a dual PPARα/δ agonist.[3]Cite error: Closing </ref> missing for <ref> tag[2][4] The FDA considers it to be a first-in-class medication.[5]

Medical uses

Elafibranor is indicated for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults who have an inadequate response to ursodeoxycholic acid, or as monotherapy in people unable to tolerate ursodeoxycholic acid.[1][2][6]

Adverse effects

The most common adverse reactions include weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.[1]

History

In 2019, the US Food and Drug Administration (FDA) granted elafibranor breakthrough therapy designation, based on phase II data, for the treatment of primary biliary cholangitis in adults 18 and older with inadequate response to ursodeoxycholic acid (UDCA).[7] The designation was granted to Genfit.[7]

In June 2024, the US FDA granted accelerated approval to elafibranor. The approval was based on positive phase III ELATIVE trial data.[8] The designation was granted to Ipsen.[9]

Society and culture

In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Iqirvo, intended for the treatment of primary biliary cholangitis (PBC).[10] The applicant for this medicinal product is Ipsen Pharma.[10] Elafibranor was authorized for medical use in the European Union in September 2024.[10][11]

In October 2024, the National Institute for Health and Care Excellence (NICE) adopted a recommendation for elafibranor for the treatment of adults with the primary biliary cholangitis based results from the phase 3 ELATIVE trial, in which 51% of patients receiving elafibranor in combination with ursodeoxycholic acid achieved a cholestasis response at week 52, compared to 4% of those in the placebo plus ursodeoxycholic acid group.[12][13]

Names

Elafibranor is the international nonproprietary name.[14]

Elafibranor is sold under the brand name Iqirvo.[10][11]

Research

Elafibranor is being studied and developed by Genfit for the treatment of endocrine and metabolic diseases such as type 2 diabetes, dyslipidemia, and metabolic dysfunction–associated steatohepatitis.[15][16][17]

References

  1. ↑ 1.0 1.1 1.2 Cite error: Invalid <ref> tag; no text was provided for refs named Iqirvo FDA label
  2. ↑ 2.0 2.1 2.2 "Ipsen's Iqirvo receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis". Ipsen (Press release). 10 June 2024. Archived from the original on 16 June 2024. Retrieved 11 June 2024.
  3. ↑ US Patent No. 7655641 "96 dpi image of original patent USPTO 7655641". http://www.google.com/patents/US7655641.pdf. 
  4. ↑ "Novel Drug Approvals for 2024". 1 October 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024. 
  5. ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025. 
  6. ↑ "Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo for Primary Biliary Cholangitis" (in de). 10 June 2024. https://www.wallstreet-online.de/nachricht/18176769-genfit-historic-milestone-achieved-with-u-s-fda-accelerated-approval-of-ipsen-s-iqirvo-for-primary-biliary-cholangitis. 
  7. ↑ 7.0 7.1 "Genfit announces FDA Grant of Breakthrough Therapy Designation to Elafibranor for the Treatment of PBC". Genfit (Press release). 18 April 2019. Archived from the original on 5 June 2024. Retrieved 11 June 2024.
  8. ↑ Ipsen (9 May 2024). A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid (Report). clinicaltrials.gov. https://clinicaltrials.gov/study/NCT04526665. Retrieved 11 June 2024. 
  9. ↑ "Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo for Primary Biliary Cholangitis" (in de). 10 June 2024. https://www.wallstreet-online.de/nachricht/18176769-genfit-historic-milestone-achieved-with-u-s-fda-accelerated-approval-of-ipsen-s-iqirvo-for-primary-biliary-cholangitis. 
  10. ↑ 10.0 10.1 10.2 10.3 "Iqirvo EPAR". 25 July 2024. https://www.ema.europa.eu/en/medicines/human/EPAR/iqirvo.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  11. ↑ 11.0 11.1 "Iqirvo PI". 23 September 2024. https://ec.europa.eu/health/documents/community-register/html/h1855.htm. 
  12. ↑ "Ipsen's Iqirvo recommended by NICE to treat rare liver disease primary biliary cholangitis - PMLiVE". 24 October 2024. https://pmlive.com/pharma_news/ipsens-iqirvo-recommended-by-nice-to-treat-rare-liver-disease-primary-biliary-cholangitis/. 
  13. ↑ "Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) (ELATIVE)". https://clinicaltrials.gov/study/NCT04526665. 
  14. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 74". WHO Drug Information 29 (3). 2015. 
  15. ↑ "Advanced Compound Status" (Press release). Genfit. Archived from the original on 11 April 2013.
  16. ↑ "GFT505 Broadens Its Therapeutic Potential" (PDF) (Press release). Archived (PDF) from the original on 10 July 2021. Retrieved 31 March 2013.
  17. ↑ "GFT505 for the treatment of nonalcoholic steatohepatitis and type 2 diabetes". Expert Opinion on Investigational Drugs 23 (10): 1441–8. October 2014. doi:10.1517/13543784.2014.954034. PMID 25164277. 



Retrieved from "https://handwiki.org/wiki/index.php?title=Chemistry:Elafibranor&oldid=4032301"