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Revision as of 20:14, 16 February 2012 editBeetstra (talk | contribs)Edit filter managers, Administrators172,074 edits Saving copy of the {{drugbox}} taken from revid 473937827 of page Aflibercept for the Chem/Drugbox validation project (updated: 'CAS_number').  Latest revision as of 04:34, 16 December 2024 edit Whywhenwhohow (talk | contribs)Autopatrolled, Extended confirmed users, Pending changes reviewers49,324 edits infobox 
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{{Short description|Pharmaceutical drug}}
{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}}
{{Use dmy dates|date=September 2024}}
{{Drugbox
{{cs1 config |name-list-style=vanc |display-authors=6}}
| Verifiedfields = changed
{{Infobox drug
| Watchedfields = changed
| Verifiedfields = changed
| verifiedrevid = 461741416
| Watchedfields = changed
| IUPAC_name =
| verifiedrevid = 477243410
| image =
| image =


<!--Clinical data--> <!-- Clinical data -->
| pronounce =
| tradename = Eylea
| licence_US = Aflibercept | tradename = Eylea, Zaltrap
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | Drugs.com = {{ubl
| Aflibercept {{drugs.com|monograph|aflibercept}}
| pregnancy_US = C
| Ziv-aflibercept {{drugs.com|monograph|ziv-aflibercept}}
| pregnancy_category =
}}
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled-->
| MedlinePlus = a612004
| legal_CA = <!-- Schedule I, II, III, IV, V, VI, VII, VIII -->
| DailyMedID = Aflibercept
| legal_UK = <!-- GSL, P, POM, CD, or Class A, B, C -->
| pregnancy_AU = D
| legal_US = Rx-only
| pregnancy_AU_comment = <ref name="Drugs.com pregnancy">{{Cite web |date=25 December 2019 |title=Ziv-aflibercept (Zaltrap) Use During Pregnancy |url=https://www.drugs.com/pregnancy/ziv-aflibercept.html |url-status=live |archive-url=https://web.archive.org/web/20201129055243/https://www.drugs.com/pregnancy/ziv-aflibercept.html |archive-date=29 November 2020 |access-date=12 March 2020 |website=Drugs.com}}</ref>
| legal_status =
| pregnancy_category = Not recommended
| routes_of_administration = Injection
| routes_of_administration = ], ]
| class = ]
| ATC_prefix = L01
| ATC_suffix = XX44
| ATC_supplemental = {{ATC|S01|LA05}}
| biosimilars = aflibercept-abzv,<ref name="Enzeevu FDA label" /><ref name="Biosimilar Drug Information" /> aflibercept-ayyh,<ref name="Pavblu FDA label" /><ref name="Biosimilar Drug Information" /> aflibercept-jbvf,<ref name="Yesafili FDA label">{{Cite web |title=Yesafili (aflibercept-jbvf) injection, for intravitreal use |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761274s000lbl.pdf |access-date=19 August 2024 |website=U.S. ] (FDA)}}</ref><ref name="Biosimilar Drug Information" /> aflibercept-mrbb,<ref name="Ahzantive FDA label" /><ref name="Biosimilar Drug Information" /> aflibercept-yszy,<ref name="Opuviz FDA label">{{Cite web |title=Opuviz (aflibercept-yszy) injection, for intravitreal use |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761350s000lbl.pdf |url-status=live |archive-url=https://web.archive.org/web/20240521025155/https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761350s000lbl.pdf |archive-date=21 May 2024 |access-date=21 May 2024}}</ref><ref name="Biosimilar Drug Information" /> Ahzantive,<ref name="Ahzantive FDA label" /><ref name="Biosimilar Drug Information" /> Enzeevu,<ref name="Enzeevu FDA label" /><ref name="Biosimilar Drug Information" /> Opuviz,<ref name="Opuviz FDA label" /><ref name="Biosimilar Drug Information" /> Pavblu,<ref name="Pavblu FDA label" /><ref name="Biosimilar Drug Information" /> Yesafili<ref name="Yesafili FDA label" /><ref name="Yesafili EPAR" /><ref>{{Cite web |date=19 September 2023 |title=Yesafili Product information |url=https://ec.europa.eu/health/documents/community-register/html/h1751.htm |url-status=live |archive-url=https://web.archive.org/web/20231002061941/https://ec.europa.eu/health/documents/community-register/html/h1751.htm |archive-date=2 October 2023 |access-date=2 October 2023 |website=Union Register of medicinal products}}</ref><ref name="Biosimilar Drug Information" />


<!--Pharmacokinetic data--> <!-- Legal status -->
| legal_AU = S4
| bioavailability =
| legal_AU_comment =
| protein_bound =
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F-->
| metabolism =
| legal_BR_comment =
| elimination_half-life =
| legal_CA = Rx-only
| excretion =
| legal_CA_comment =<ref>{{Cite web |date=2 February 2024 |title=Regulatory Decision Summary for Eylea HD |url=https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708532368148 |url-status=live |archive-url=https://web.archive.org/web/20240402033640/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS1708532368148 |archive-date=2 April 2024 |access-date=2 April 2024 |website=Drug and Health Products Portal}}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled-->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = POM
| legal_UK_comment =
| legal_US = Rx-only
| legal_US_comment = <ref name="Eylea FDA label" /><ref name="Zaltrap FDA label" /><ref name="Eylea HD FDA label">{{Cite web |date=18 August 2023 |title=Eylea HD- aflibercept injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86d8848b-111b-4da9-8957-7cccef1b8f66 |url-status=live |archive-url=https://web.archive.org/web/20230829040233/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86d8848b-111b-4da9-8957-7cccef1b8f66 |archive-date=29 August 2023 |access-date=28 August 2023 |website=DailyMed}}</ref>
| legal_EU = Rx-only
| legal_EU_comment =<ref name="Eylea EPAR" /><ref name="Zaltrap EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV-->
| legal_UN_comment =
| legal_status = Rx-only


<!--Identifiers--> <!-- Pharmacokinetic data -->
| bioavailability =
| CAS_number_Ref = {{cascite|changed|??}}
| protein_bound =
| CAS_number = <!-- blanked - oldvalue: 862111-32-8 -->
| metabolism =
| ATC_prefix = S01
| metabolites =
| ATC_suffix = LA05
| onset =
| ATC_supplemental =
| elimination_half-life =
| PubChem =
| duration_of_action =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| excretion =
| DrugBank =
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 15C2VL427D
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D09574
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = NA


<!--Chemical data--> <!-- Identifiers -->
| CAS_number_Ref = {{cascite|changed|??}}
| chemical_formula =
| CAS_number = 862111-32-8
| C=4318 | H=6788 | N=1164 | O=1304 | S=32
| CAS_supplemental =
| molecular_weight = 96.90 ]
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB08885
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = none
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 15C2VL427D
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D09574
| ChEBI =
| ChEMBL = 1742982
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = ziv-aflibercept

<!-- Chemical and physical data -->
| IUPAC_name =
| C = 4318
| H = 6788
| N = 1164
| O = 1304
| S = 32
}} }}

'''Aflibercept''', sold under the brand names '''Eylea''' and '''Zaltrap''' among others, is a medication used to treat ] and metastatic ].<ref name="Eylea EPAR">{{Cite web |date=9 July 2019 |title=Eylea EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/eylea |url-status=live |archive-url=https://web.archive.org/web/20201109043834/https://www.ema.europa.eu/en/medicines/human/EPAR/eylea |archive-date=9 November 2020 |access-date=12 March 2020 |website=] (EMA)}}</ref><ref name="Zaltrap EPAR">{{Cite web |date=12 November 2019 |title=Zaltrap EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap |url-status=live |archive-url=https://web.archive.org/web/20201111223030/https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap |archive-date=11 November 2020 |access-date=12 March 2020 |website=] (EMA)}}</ref> It was developed by ].

It is an inhibitor of ] (VEGF).<ref name="pmid18499749">{{Cite journal |vauthors=Fraser HM, Wilson H, Silvestri A, Morris KD, Wiegand SJ |date=September 2008 |title=The role of vascular endothelial growth factor and estradiol in the regulation of endometrial angiogenesis and cell proliferation in the marmoset |url=http://endo.endojournals.org/cgi/pmidlookup?view=long&pmid=18499749 |url-status=live |journal=Endocrinology |volume=149 |issue=9 |pages=4413–20 |doi=10.1210/en.2008-0325 |pmid=18499749 |archive-url=https://web.archive.org/web/20191208165552/http://endo.endojournals.org/cgi/pmidlookup?view=long&pmid=18499749 |archive-date=8 December 2019 |access-date=3 July 2008 |doi-access=free}}</ref><ref name="pmid18388198">{{Cite journal |vauthors=Duncan WC, van den Driesche S, Fraser HM |date=July 2008 |title=Inhibition of vascular endothelial growth factor in the primate ovary up-regulates hypoxia-inducible factor-1alpha in the follicle and corpus luteum |journal=Endocrinology |volume=149 |issue=7 |pages=3313–20 |doi=10.1210/en.2007-1649 |pmid=18388198 |doi-access=free}}</ref> Aflibercept is a recombinant fusion protein consisting of the extracellular domains of human VEGF receptor 1 and 2 fused to the Fc portion of human IgG1.<ref name="Eydenzelt EPAR" /> By acting as a soluble decoy for the natural VEGF receptors, aflibercept inhibits their activation, thereby reducing angiogenesis.<ref name="Eydenzelt EPAR" />

==Medical uses==
Aflibercept (Eylea) is ] for the treatment of people with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity.<ref name="Eylea FDA label" />

Aflibercept (Zaltrap), in combination with ], ], and ] (known as ]), is indicated for the treatment of people with metastatic colorectal cancer that is resistant to, or has progressed following, an oxaliplatin-containing regimen.<ref name="Zaltrap FDA label" /><ref name="Zaltrap EPAR" />

It is used for the treatment of wet macular degeneration and is administered as an ] injection, that is, into the eye.<ref name="Eylea FDA label">{{Cite web |date=12 August 2019 |title=Eylea- aflibercept injection, solution |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f96cfd69-da34-41ee-90a9-610a4655cd1c |url-status=live |archive-url=https://web.archive.org/web/20210325013817/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f96cfd69-da34-41ee-90a9-610a4655cd1c |archive-date=25 March 2021 |access-date=13 August 2020 |website=DailyMed}}</ref> For cancer treatment, it is given ]ly in combination with fluorouracil, leucovorin, and irinotecan.<ref name="Zaltrap FDA label">{{Cite web |date=10 June 2020 |title=Zaltrap- ziv-aflibercept solution, concentrate |url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6725df6-50ee-4b0a-b900-d02ba634395d |url-status=live |archive-url=https://web.archive.org/web/20200804175756/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6725df6-50ee-4b0a-b900-d02ba634395d |archive-date=4 August 2020 |access-date=13 August 2020 |website=DailyMed}}</ref>

In July 2014, aflibercept (Eylea) was approved for the treatment of people with visual impairment due to diabetic macular edema<ref>{{Cite web |date=18 November 2011 |title=Eylea (aflibercept) FDA Approval History |url=https://www.drugs.com/history/eylea.html |url-status=live |archive-url=https://web.archive.org/web/20240619093414/https://www.drugs.com/history/eylea.html |archive-date=19 June 2024 |access-date=26 August 2024 |website=Drugs.com}}</ref> In May 2019, the US FDA expanded the indication for aflibercept to include all stages of ].<ref>{{Cite press release |title=FDA Approves Eylea (aflibercept) Injection for Diabetic Retinopathy |date=13 May 2019 |url=https://investor.regeneron.com/news-releases/news-release-details/fda-approves-eylear-aflibercept-injection-diabetic-retinopathy |access-date=28 June 2023 |url-status=live |archive-url=https://web.archive.org/web/20190514055732/https://investor.regeneron.com/news-releases/news-release-details/fda-approves-eylear-aflibercept-injection-diabetic-retinopathy |archive-date=14 May 2019 |website=Regeneron Pharmaceuticals Inc.}}</ref>

In February 2023, the US FDA approved aflibercept (Eylea) as a treatment for retinopathy of prematurity.<ref>{{Cite press release |title=Eylea (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA |date=8 February 2023 |url=https://investor.regeneron.com/news-releases/news-release-details/eylear-aflibercept-injection-approved-first-pharmacologic |access-date=28 June 2023 |url-status=live |archive-url=https://web.archive.org/web/20230628230201/https://investor.regeneron.com/news-releases/news-release-details/eylear-aflibercept-injection-approved-first-pharmacologic |archive-date=28 June 2023 |website=Regeneron Pharmaceuticals Inc.}}</ref>

==Contraindications==
Aflibercept (Eylea) is contraindicated in people with infections or active ]s of or near the eye,<ref name="Eylea FDA label" /> while aflibercept (Zaltrap) has no contraindications.<ref name="Zaltrap FDA label" />

==Adverse effects==
Common adverse effects of the eye formulation include conjunctival ], eye pain, cataract, ], ]s, and ].<ref name="Eylea FDA label" />

Aflibercept (Zaltrap) has adverse effects typical of anti-cancer drugs, such as reduced blood cell count (], ], ]), gastrointestinal disorders like diarrhea and abdominal pain, and fatigue. Another common effect is ] (increased blood pressure).<ref name="Zaltrap FDA label" />

==Interactions==
No interactions are described for either formulation.<ref name="Eylea FDA label" /><ref name="Zaltrap FDA label" />

==Mechanism of action==
In wet macular degeneration, abnormal blood vessels grow in the ], a layer of ] in the eye, leading to blood and protein leakage below the macula.

Aflibercept (Zaltrap) binds to circulating VEGFs and acts like a "VEGF trap".<ref>{{Cite news |date=7 February 2013 |title=Aflibercept Approved for Colorectal Cancer in Europe |url=http://www.medscape.com/viewarticle/778918 |url-status=live |archive-url=https://web.archive.org/web/20130210084012/http://www.medscape.com/viewarticle/778918 |archive-date=10 February 2013}}</ref> It thereby inhibits the activity of the vascular endothelial growth factor subtypes ] and ], as well as to ] (PGF), inhibiting the growth of new blood vessels in the choriocapillaris or the tumour, respectively.<ref name=Apr2011/> The aim of the cancer treatment, so to speak, is to starve the tumor.

==Composition==
Aflibercept is a ] ] consisting of ] (VEGF)-binding portions from the extracellular domains of human VEGF ]s 1 and 2, that are fused to the Fc portion of the human IgG1 ].<ref name="Zaltrap FDA" />

==History==
Regeneron commenced clinical testing of aflibercept in cancer in 2001.<ref name="Timeline">{{Cite web |year=1988 |title=Our History - A 25 year commitment to repeated innovation |url=https://www.regeneron.com/history |url-status=live |archive-url=https://web.archive.org/web/20170517181158/https://www.regeneron.com/history |archive-date=17 May 2017 |access-date=7 May 2018 |website=www.regeneron.com}}</ref> In 2003, Regeneron signed a major deal with ] to develop aflibercept in the field of cancer.<ref>{{Cite web |last=Hoffmann |first=Candace |date=8 September 2003 |title=Aventis inks deal with Regeneron for collaboration on cancer therapy |url=http://www.firstwordpharma.com/node/215613 |url-status=dead |archive-url=https://web.archive.org/web/20140414211959/http://www.firstwordpharma.com/node/215613 |archive-date=14 April 2014 |website=firstwordpharma}}</ref> In 2004 Regeneron started testing the compound, locally delivered, in proliferative eye diseases,<ref name=Timeline/> and in 2006 Regeneron and Bayer signed an agreement to develop the eye indications.<ref>{{Cite web |date=19 October 2006 |title=Bayer HealthCare Signs On to Help Develop Regeneron's VEGF Trap-Eye |url=https://www.genengnews.com/news/bayer-healthcare-signs-on-to-help-develop-regenerons-vegf-trap-eye/ |access-date=17 September 2024 |website=GEN - Genetic Engineering and Biotechnology News}}</ref>

==Society and culture==
===Legal status===
In November 2011, the US ] (FDA) approved aflibercept for the treatment of wet macular degeneration.<ref>{{Cite web |date=18 November 2011 |title=Drug Approval Package: Eylea (aflibercept) NDA #125387 |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387s0000TOC.cfm |url-status=live |archive-url=https://web.archive.org/web/20231017030822/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387s0000toc.cfm |archive-date=17 October 2023 |access-date=21 May 2024 |website=U.S. ] (FDA)}}</ref><ref>{{Cite web |date=19 November 2011 |title=FDA Approves Eylea for Macular Degeneration |url=http://www.medpagetoday.com/Ophthalmology/GeneralOphthalmology/29811 |url-status=live |archive-url=https://web.archive.org/web/20130528151430/http://www.medpagetoday.com/Ophthalmology/GeneralOphthalmology/29811 |archive-date=28 May 2013 |access-date=16 October 2013 |publisher=MedpageToday.com |vauthors=Gever J}}</ref>

In August 2012, the US FDA approved aflibercept (Zaltrap) for use in combination with ], ] and ] to treat adults with metastatic colorectal cancer that is resistant to, or has progressed following, an ]‑containing regimen.<ref>{{Cite web |date=6 September 2012 |title=Drug Approval Package: Zaltrap (ziv-aflibercept) NDA #125418 |url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418_zaltrap_toc.cfm |url-status=live |archive-url=https://web.archive.org/web/20220926220226/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125418_zaltrap_toc.cfm |archive-date=26 September 2022 |access-date=21 May 2024 |website=U.S. ] (FDA)}}</ref><ref name="Zaltrap FDA">{{Cite web |date=3 August 2012 |title=Ziv-Aflibercept |url=https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm314438.htm |url-status=dead |archive-url=https://web.archive.org/web/20131016041012/https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm314438.htm |archive-date=16 October 2013 |access-date=16 October 2013 |publisher=U.S. ] (FDA)}}</ref><ref>{{Cite web |date=17 December 2012 |title=2012 Notifications |url=https://www.fda.gov/drugs/resources-information-approved-drugs/2012-notifications |url-status=live |archive-url=https://web.archive.org/web/20191226010037/https://www.fda.gov/drugs/resources-information-approved-drugs/2012-notifications |archive-date=26 December 2019 |access-date=21 May 2024 |website=U.S. ] (FDA)}}</ref><ref>{{Cite press release |title=U.S. FDA Approves Zaltrap (ziv-aflibercept) After Priority Review for Previously Treated Metastatic Colorectal Cancer |date=3 August 2012 |publisher=Sanofi and Regeneron |url=https://www.prnewswire.com/news-releases/us-fda-approves-zaltrap-ziv-aflibercept-after-priority-review-for-previously-treated-metastatic-colorectal-cancer-164919796.html |via=PR Newswire |access-date=21 May 2024 |url-status=live |archive-url=https://web.archive.org/web/20240521024356/https://www.prnewswire.com/news-releases/us-fda-approves-zaltrap-ziv-aflibercept-after-priority-review-for-previously-treated-metastatic-colorectal-cancer-164919796.html |archive-date=21 May 2024}}</ref> To avoid confusion with the version that is injected into the eye, the FDA assigned a new name, ''ziv''-aflibercept, to the active ingredient.<ref>{{Cite web |last=Serebrov |first=Mari |title=GPhA: Common Name is Key to Biosimilar Competition |url=http://www.bioworld.com/content/gpha-common-name-key-biosimilar-competition-1 |url-status=dead |archive-url=https://web.archive.org/web/20131213045215/http://www.bioworld.com/content/gpha-common-name-key-biosimilar-competition-1 |archive-date=13 December 2013 |website=BioWorld}}</ref>

In November 2012, the ] (EMA) approved aflibercept (Eylea) for the treatment of wet macular degeneration.<ref name="Eylea EPAR" /><ref>{{Cite web |title=Aflibercept Injection Approved for the Treatment of Wet Age-Related Macular Degeneration in Europe |url=http://www.amd-fruehdiagnose.de/eylea/eylea-aflibercept-injection-approved-treatment-of-wet-age-related-macular-degeneration-europe.htm |url-status=live |archive-url=https://web.archive.org/web/20131125185521/http://www.amd-fruehdiagnose.de/eylea/eylea-aflibercept-injection-approved-treatment-of-wet-age-related-macular-degeneration-europe.htm |archive-date=25 November 2013 |access-date=16 October 2013 |publisher=Amd-fruehdiagnose.de}}</ref>

In February 2013, the ] (EMA) approved aflibercept (Zaltrap) for the treatment of adults with metastatic colorectal cancer for whom treatment based on ] has not worked or the cancer got worse.<ref name="Zaltrap EPAR" /><ref>{{Cite web |title=Zaltrap : EPAR - Summary for the public |url=https://www.ema.europa.eu/documents/overview/zaltrap-epar-summary-public_en.pdf |url-status=live |archive-url=https://web.archive.org/web/20131016041239/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002532/WC500139486.pdf |archive-date=16 October 2013 |access-date=1 July 2013}}</ref> Aflibercept (Zaltrap) is used with irinotecan, 5-fluorouracil, and folinic acid.<ref name="Zaltrap EPAR" />

In August 2023, the FDA approved aflibercept (Eylea) for the treatment of wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.<ref name="Regeneron PR 20230813">{{Cite press release |title=Eylea HD (aflibercept) Injection 8 mg Approved by FDA for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) |date=18 August 2023 |publisher=Regeneron Pharmaceuticals |url=https://www.globenewswire.com/news-release/2023/08/18/2728276/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Approved-by-FDA-for-Treatment-of-Wet-Age-related-Macular-Degeneration-wAMD-Diabetic-Macular-Edema-DME-and-Diabetic-Retinopathy-DR.html |via=GlobeNewswire |access-date=26 August 2024 |url-status=live |archive-url=https://web.archive.org/web/20230826191738/https://www.globenewswire.com/news-release/2023/08/18/2728276/0/en/EYLEA-HD-aflibercept-Injection-8-mg-Approved-by-FDA-for-Treatment-of-Wet-Age-related-Macular-Degeneration-wAMD-Diabetic-Macular-Edema-DME-and-Diabetic-Retinopathy-DR.html |archive-date=26 August 2023}}</ref>

====Biosimilars====
Yesafili was approved for medical use in the European Union in September 2023.<ref name="Yesafili EPAR">{{Cite web |date=15 September 2023 |title=Yesafili EPAR |url=https://www.ema.europa.eu/en/medicines/human/EPAR/yesafili |url-status=live |archive-url=https://web.archive.org/web/20240217185524/https://www.ema.europa.eu/en/medicines/human/EPAR/yesafili |archive-date=17 February 2024 |access-date=21 May 2024 |website=European Medicines Agency}}</ref>

In May 2024, aflibercept-jbvf (Yesafili)<ref name="Yesafili FDA label" /> and aflibercept-yszy (Opuviz)<ref name="Opuviz FDA label" /> were approved for medical use in the United States.<ref name="FDA PR 20240520">{{Cite press release |title=FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions |date=20 May 2024 |url=https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye |access-date=21 May 2024 |url-status=live |archive-url=https://web.archive.org/web/20240521025145/https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye |archive-date=21 May 2024 |website=U.S. ] (FDA)}}</ref><ref name="Biosimilar Drug Information">{{Cite web |date=26 August 2024 |title=Biosimilar Drug Information |url=https://www.fda.gov/drugs/biosimilars/biosimilar-product-information |url-status=live |archive-url=https://web.archive.org/web/20210828185647/https://www.fda.gov/drugs/biosimilars/biosimilar-product-information |archive-date=28 August 2021 |access-date=26 August 2024 |website=U.S. ] (FDA)}}</ref>

Aflibercept-mrbb (Ahzantive) was approved for medical use in the United States in June 2024.<ref name="Ahzantive FDA label">{{Cite web |title=Ahzantive |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761378s000lbl.pdf |access-date=26 August 2024 |archive-date=5 October 2024 |archive-url=https://web.archive.org/web/20241005181858/https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761378s000lbl.pdf |url-status=live }}</ref><ref name="Ahzantive approval letter">{{Cite web |title=Ahzantive Biologic License Application Approval |url=https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761378Orig1s000ltr.pdf |access-date=26 August 2024 |archive-date=8 September 2024 |archive-url=https://web.archive.org/web/20240908055807/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761378Orig1s000ltr.pdf |url-status=live }}</ref><ref name="Biosimilar Drug Information" /> It is a biosimilar to Eylea.<ref name="Ahzantive FDA label" />

In August 2024, aflibercept-abzv (Enzeevu) was approved for medical use in the United States.<ref name="Enzeevu FDA label">{{Cite web |title=Enzeevu (aflibercept-abzv) injection, for intravitreal use |url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761382s000lbl.pdf |access-date=26 August 2024 |archive-date=8 September 2024 |archive-url=https://web.archive.org/web/20240908055807/https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761382s000lbl.pdf |url-status=live }}</ref><ref name="Enzeevu approval letter">{{Cite web |title=Enzeevu Biologic License Application Approval |url=https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761382Orig1s000ltr.pdf |access-date=26 August 2024 |archive-date=5 October 2024 |archive-url=https://web.archive.org/web/20241005181859/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761382Orig1s000ltr.pdf |url-status=live }}</ref><ref name="Biosimilar Drug Information" /> It is a biosimilar to Eylea.<ref name="Enzeevu FDA label" />

In August 2024, aflibercept-ayyh (Pavblu) was approved for medical use in the United States.<ref name="Pavblu FDA label">{{cite web | title=Pavblu- aflibercept-ayyh injection, solution | website=DailyMed | date=28 October 2024 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c61062f3-80ec-4a20-8c28-46e468592a06 | access-date=11 November 2024}}</ref><ref name="Pavblu approval letter">{{Cite web |title=Pavblu Biologic License Application Approval |url=https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761298Orig1s000ltr.pdf |access-date=26 August 2024 |archive-date=8 September 2024 |archive-url=https://web.archive.org/web/20240908060318/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761298Orig1s000ltr.pdf |url-status=live }}</ref><ref name="Biosimilar Drug Information" /> It is a biosimilar to Eylea.<ref name="Pavblu FDA label" />

In September 2024, the ] (CHMP) of the ] adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Opuviz, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME) and visual impairment due to myopic choroidal neovascularization (myopic CNV).<ref name="Opuviz EPAR" /> The applicant for this medicinal product is Samsung Bioepis NL B.V.<ref name="Opuviz EPAR" /> Opuviz is a biosimilar medicinal product that is highly similar to the reference product Eylea.<ref name="Opuviz EPAR">{{cite web | title=Pavblu EPAR | website=] (EMA) | date=19 September 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/opuviz | access-date=21 September 2024 | archive-date=21 September 2024 | archive-url=https://web.archive.org/web/20240921040006/https://www.ema.europa.eu/en/medicines/human/EPAR/opuviz | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>

In September 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Afqlir, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME) and visual impairment due to myopic choroidal neovascularization (myopic CNV).<ref name="Afqlir EPAR" /> The applicant for this medicinal product is Sandoz GmbH.<ref name="Afqlir EPAR" /> Afqlir is a biosimilar medicinal product that is highly similar to the reference product Eylea.<ref name="Afqlir EPAR">{{cite web | title=Afqlir EPAR | website=] (EMA) | date=19 September 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/afqlir | access-date=21 September 2024 | archive-date=21 September 2024 | archive-url=https://web.archive.org/web/20240921040639/https://www.ema.europa.eu/en/medicines/human/EPAR/afqlir | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Afqlir was authorized for use in the EU in November 2024.<ref>{{cite web | title=Afqlir PI | website=Union Register of medicinal products | date=14 November 2024 | url=https://ec.europa.eu/health/documents/community-register/html/h1867.htm | access-date=20 November 2024}}</ref><ref>{{Cite news |title=Sandoz receives European Commission approval for Afqlir (aflibercept), further strengthening leading biosimilar portfolio |url=https://finance.yahoo.com/news/sandoz-receives-european-commission-approval-060000286.html |work=]}}</ref>

In November 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Ahzantive, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).<ref name="Ahzantive EPAR" /> The applicant for this medicinal product is Klinge Biopharma GmbH.<ref name="Ahzantive EPAR" /> Ahzantive is a biosimilar medicinal product that is highly similar to the reference product Eylea.<ref name="Ahzantive EPAR">{{cite web | title=Ahzantive EPAR | website=European Medicines Agency (EMA) | date=14 November 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ahzantive | access-date=16 November 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref name="CHMP 202411" />

In November 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Baiama, intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).<ref name="Baiama EPAR" /> The applicant for this medicinal product is Formycon AG.<ref name="Baiama EPAR" /> Baiama is a biosimilar medicinal product that is highly similar to the reference product Eylea.<ref name="Baiama EPAR">{{cite web | title=Baiama EPAR | website=European Medicines Agency (EMA) | date=14 November 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/baiama | access-date=16 November 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref name="CHMP 202411">{{cite press release | title=Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 November 2024 | website=] (EMA) | date=15 November 2024 | url=https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-11-14-november-2024 | access-date=16 November 2024}}</ref>

In December 2024, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Eydenzelt, intended for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).<ref name="Eydenzelt EPAR" /> The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.<ref name="Eydenzelt EPAR" /> Eydenzelt is a biosimilar medicinal product.<ref name="Eydenzelt EPAR" /> It is highly similar to the reference product Eylea.<ref name="Eydenzelt EPAR">{{cite web | title=Eydenzelt EPAR | website=European Medicines Agency (EMA) | date=12 December 2024 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/eydenzelt | access-date=16 December 2024}} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref>

===Economics===
In March 2015, aflibercept was one of a group of drugs delisted from the UK Cancer Drugs Fund.<ref>{{Cite web |date=19 November 2015 |title=Cancer: Drugs:Written question - HL3340 |url=https://questions-statements.parliament.uk/written-questions/detail/2015-11-05/HL3340 |url-status=live |archive-url=https://web.archive.org/web/20180402225615/https://www.parliament.uk/written-questions-answers-statements/written-question/lords/2015-11-05/HL3340 |archive-date=2 April 2018 |publisher=UK Parliament}}</ref> In 2017, injections of aflibercept (] code J0178) were responsible for the most billing to ] Part B, at {{US$|2.36 billion}}.<ref>{{Cite web |title=Physician/Supplier National Data |url=https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareFeeforSvcPartsAB/Downloads/LEVEL2CHARG17.pdf |url-status=live |archive-url=https://web.archive.org/web/20180817194521/https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareFeeforSvcPartsAB/Downloads/LEVEL2CHARG17.pdf |archive-date=17 August 2018 |access-date=11 June 2019 |website=]}}</ref>

==Research==
In March 2011, aflibercept failed its primary ] of overall survival in the Vital ] for second-line treatment of locally advanced or metastatic ], although it improved the secondary endpoint of progression-free survival.<ref name=Apr2011/><ref>{{Cite news |date=11 March 2011 |title=Regeneron and Sanofi-Aventis Cancer Drug Misses Phase III Primary Endpoint but Meets Secondary Targets |url=http://www.genengnews.com/gen-news-highlights/regeneron-and-sanofi-aventis-cancer-drug-misses-phase-iii-primary-endpoint-but-meets-secondary-targets/81244807/ |url-status=live |archive-url=https://web.archive.org/web/20120406205554/http://www.genengnews.com/gen-news-highlights/regeneron-and-sanofi-aventis-cancer-drug-misses-phase-iii-primary-endpoint-but-meets-secondary-targets/81244807/ |archive-date=6 April 2012}}</ref>

In April 2011, aflibercept improved its primary endpoint of overall survival in the Velour phase III clinical trial for ] for metastatic ].<ref name="Apr2011">{{Cite news |date=27 April 2011 |title=Regeneron and Sanofi-Aventis Report Positive Phase III mCRC Trial Data |url=https://www.genengnews.com/news/regeneron-and-sanofi-aventis-report-positive-phase-iii-mcrc-trial-data/ |url-status=live |archive-url=https://web.archive.org/web/20120202212928/http://www.genengnews.com/gen-news-highlights/regeneron-and-sanofi-aventis-report-positive-phase-iii-mcrc-trial-data/81245067 |archive-date=2 February 2012}}</ref>

Aflibercept was also in a phase III trial for ] {{as of|2011|4|lc=on}}.<ref name=Apr2011/>

A 2016 ] examined outcomes comparing aflibercept versus ranibizumab injections in over 2400 people with neovascular AMD, from two randomized controlled trials. Both treatment options yielded similar improvements in visual acuity and morphological outcomes, though the authors note that the aflibercept treatment regimen has the potential to reduce treatment burden and risks from frequent injections.<ref name="Sarwar">{{Cite journal |vauthors=Sarwar S, Clearfield E, Soliman MK, Sadiq MA, Baldwin AJ, Hanout M, Agarwal A, Sepah YJ, Do DV, Nguyen QD |date=February 2016 |title=Aflibercept for neovascular age-related macular degeneration |journal=The Cochrane Database of Systematic Reviews |volume=2016 |issue=2 |pages=CD011346 |doi=10.1002/14651858.CD011346.pub2 |pmc=5030844 |pmid=26857947}}</ref>

A 2017 review update studying the effects of anti-VEGF drugs on ] found that while all three studied treatments have advantages over laser therapy, there was moderate evidence that aflibercept is significantly favored in all measured efficacy outcomes over ] and ], after one year, longer term advantages were unclear.<ref>{{Cite journal |vauthors=Virgili G, Curran K, Lucenteforte E, Peto T, Parravano M |date=June 2023 |title=Anti-vascular endothelial growth factor for diabetic macular oedema: a network meta-analysis |journal=The Cochrane Database of Systematic Reviews |volume=2023 |issue=6 |pages=CD007419 |doi=10.1002/14651858.CD007419.pub7 |pmc=10294542 |pmid=38275741 |collaboration=Cochrane Eyes and Vision Group}}</ref>

==References==
{{reflist}}

==External links==
* {{Cite web |title=Ziv-aflibercept Injection |url=https://medlineplus.gov/druginfo/meds/a613003.html |website=MedlinePlus}}
* {{Cite web |date=15 August 2012 |title=Ziv-aflibercept |url=https://www.cancer.gov/about-cancer/treatment/drugs/ziv-aflibercept |access-date=10 February 2023 |website=National Cancer Institute}}

{{Extracellular chemotherapeutic agents}}
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