Elafibranor Explained

Width:275
Tradename:Iqirvo
Dailymedid:Elafibranor
Routes Of Administration:By mouth
Class:Antihyperlipidemic
Atc Prefix:A05
Atc Suffix:AX06
Legal Us:Rx-only
Legal Us Comment:[1]
Cas Number:923978-27-2
Pubchem:9864881
Drugbank:DB05187
Chemspiderid:8040573
Unii:2J3H5C81A5
Kegg:D11208
Chembl:3707395
Pdb Ligand:MUO
Synonyms:GFT505, SureCN815512
Iupac Name:2-[2,6 Dimethyl-4-[3-[4-(methylthio)phenyl]-3-oxo-1(E)-propenyl]phenoxyl]-2-methylpropanoic acid[2]
C:22
H:24
O:4
S:1
Smiles:O=C(O)C(Oc1c(cc(cc1C)\C=C\C(=O)c2ccc(SC)cc2)C)(C)C
Stdinchi:1S/C22H24O4S/c1-14-12-16(13-15(2)20(14)26-22(3,4)21(24)25)6-11-19(23)17-7-9-18(27-5)10-8-17/h6-13H,1-5H3,(H,24,25)/b11-6+
Stdinchikey:AFLFKFHDSCQHOL-IZZDOVSWSA-N

Elafibranor (INN[3]), sold under the brand name Iqirvo, is a medication used for the treatement of primary biliary cholangitis.

Elafibranor is a dual PPARα/δ agonist.[4] [5] Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists, both of which activate PPAR-alpha, PPAR-gamma, and PPAR-delta in vitro.

In June 2024, the US Food and Drug Administration (FDA) granted accelerated approval to elafibranor.[6]

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.[7] [8]

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.

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).[9] The designation was granted to Genfit.

In June 2024, the US FDA granted accelerated approval to elafibranor. The approval was based on positive phase III ELATIVE trial data.[10] The designation was granted to Ipsen.[11]

Society and culture

Legal status

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). The applicant for this medicinal product is Ipsen Pharma.[12]

Research

This chemical compound is also being studied and developed by Genfit for the treatment of endocrine and metabolic diseases such as type 2 diabetes, dyslipidemia, and MASH.[13] [14] [15]

Notes and References

  1. Web site: Iqirvo- elafibranor tablet, film coated . DailyMed . 10 June 2024 . 16 June 2024 . 16 June 2024 . https://web.archive.org/web/20240616015714/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d78aa14f-6ec1-4b1d-a4ae-e48658137a25 . live .
  2. Cariou B, Zaïr Y, Staels B, Bruckert E . Effects of the new dual PPAR α/δ agonist GFT505 on lipid and glucose homeostasis in abdominally obese patients with combined dyslipidemia or impaired glucose metabolism . Diabetes Care . 34 . 9 . 2008–14 . September 2011 . 21816979 . 3161281 . 10.2337/dc11-0093 .
  3. ((World Health Organization)) . 2015 . International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 74 . WHO Drug Information . 29 . 3 . 10665/331070 . free . World Health Organization .
  4. Web site: 96 dpi image of original patent USPTO 7655641. 31 March 2013 .
  5. GFT-505 . Drugs of the Future . 2012 . 37 . 8 . 555–559 . 10.1358/dof.2012.037.08.1835977 . Vázquez-Carrera . M. . 258323049 .
  6. FDA Roundup: June 11, 2024 . U.S. Food and Drug Administration (FDA) . 11 June 2024 . 12 June 2024 . 11 June 2024 . https://web.archive.org/web/20240611210834/https://www.fda.gov/news-events/press-announcements/fda-roundup-june-11-2024 . live .
  7. Ipsen's Iqirvo receives U.S. FDA accelerated approval as a first-in-class PPAR treatment for primary biliary cholangitis . Ipsen . 10 June 2024 . 11 June 2024 . 16 June 2024 . https://web.archive.org/web/20240616015617/https://www.ipsen.com/press-releases/ipsens-iqirvo-receives-u-s-fda-accelerated-approval-as-a-first-in-class-ppar-treatment-for-primary-biliary-cholangitis/ . live .
  8. Web site: 10 June 2024 . Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo for Primary Biliary Cholangitis . 11 June 2024 . wallstreet-online.de . de . 16 June 2024 . https://web.archive.org/web/20240616015717/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 . live .
  9. Genfit announces FDA Grant of Breakthrough Therapy Designation to Elafibranor for the Treatment of PBC . Genfit . 18 April 2019 . 11 June 2024 . 5 June 2024 . https://web.archive.org/web/20240605152923/https://ir.genfit.com/news-releases/news-release-details/genfit-announces-fda-grant-breakthrough-therapy-designation . live .
  10. 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 . Ipsen . 9 May 2024 . clinicaltrials.gov . NCT04526665 . 11 June 2024 . 2 May 2024 . https://web.archive.org/web/20240502004031/https://clinicaltrials.gov/study/NCT04526665 . live .
  11. Web site: 10 June 2024 . Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen's Iqirvo for Primary Biliary Cholangitis . 11 June 2024 . wallstreet-online.de . de . 11 June 2024 . https://web.archive.org/web/20240611075953/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 . live .
  12. Web site: Iqirvo EPAR . European Medicines Agency . 25 July 2024 . 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  13. Advanced Compound Status . https://archive.today/20130411003245/http://www.genfit.com/en/science-discovery/therapeutic-commitment/advanced-compound-status/ . dead . 11 April 2013 . Genfit .
  14. GFT505 Broadens Its Therapeutic Potential . 31 March 2013 . 10 July 2021 . https://web.archive.org/web/20210710134732/http://hugin.info/143426/R/1672617/544056.pdf . live .
  15. Cariou B, Staels B . GFT505 for the treatment of nonalcoholic steatohepatitis and type 2 diabetes . Expert Opinion on Investigational Drugs . 23 . 10 . 1441–8 . October 2014 . 25164277 . 10.1517/13543784.2014.954034 . 3190253 .

This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Elafibranor".

Except where otherwise indicated, Everything.Explained.Today is © Copyright 2009-2024, A B Cryer, All Rights Reserved. Cookie policy.