revakinagene taroretcel
{{Short description|Medication}}
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| tradename = Encelto
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| DailyMedID = Revakinagene taroretcel
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| routes_of_administration = Intravitreal implantation
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| legal_US = Rx-only
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| UNII = Q7V7NYG6GM
| UNII2 = J3LVA7RZT2
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| synonyms = NTC-201-6A, revakinagene taroretcel-lwey
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Revakinagene taroretcel, sold under the brand name Encelto, is an allogeneic encapsulated cell-based gene therapy used for the treatment of macular telangiectasia type 2.{{cite journal | vauthors = Rim MH, Dean C, Aliaj E, Karas BL, Barada F, Levitsky AM | title = Recent and anticipated novel drug approvals (3Q 2024 through 2Q 2025) | journal = American Journal of Health-System Pharmacy | volume = 81 | issue = 22 | pages = 1103–1108 | date = November 2024 | pmid = 39194065 | doi = 10.1093/ajhp/zxae242 }} Revakinagene taroretcel is administered into the recipient's eye during a single surgical procedure.{{cite web | title=FDA Roundup: March 7, 2025 | website=U.S. Food and Drug Administration | date=7 March 2025 | url=https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2025 | archive-url=https://web.archive.org/web/20250307232529/https://www.fda.gov/news-events/press-announcements/fda-roundup-march-7-2025 | url-status=dead | archive-date=7 March 2025 | access-date=7 March 2025}} {{PD-notice}}
Revakinagene taroretcel works by expressing recombinant human ciliary neurotrophic factor, which is a factor that may promote the survival and maintenance of the macular photoreceptors.
Revakinagene taroretcel was approved for medical use in the United States in March 2025.{{cite web | title=Encelto | website=U.S. Food and Drug Administration | date=1 October 2024 | url=https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information/encelto | archive-url=https://web.archive.org/web/20250307223027/https://www.fda.gov/vaccines-blood-biologics/center-biologics-evaluation-and-research-cber-product-approval-information/encelto | url-status=dead | archive-date=7 March 2025 | access-date=7 March 2025}}
Medical uses
Revakinagene taroretcel is indicated for the treatment of adults with idiopathic macular telangiectasia type 2.
Macular telangiectasia type 2 is a rare progressive disease of the macula (portion of the eye that process sharp central vision), leading to degeneration of the photoreceptors which are specialized light-detecting cells in the back of the eye.
Society and culture
= Legal status=
Revakinagene taroretcel was approved for medical use in the United States in March 2025.{{cite press release | title=Neurotech's Encelto (revakinagene taroretcel-lwey) Approved by the FDA for the Treatment of Macular Telangiectasia Type 2 (MacTel) | publisher=Neurotech | via=Business Wire | date=6 March 2025 | url=https://www.businesswire.com/news/home/20250306180680/en/Neurotech%E2%80%99s-ENCELTO%E2%84%A2-revakinagene-taroretcel-lwey-Approved-by-the-FDA-for-the-Treatment-of-Macular-Telangiectasia-Type-2-MacTel/ | access-date=7 March 2025}}
= Names =
Revakinagene taroretcel is the international nonproprietary name{{cite journal | vauthors = ((World Health Organization)) | year = 2021 | title = International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85 | journal = WHO Drug Information | volume = 35 | issue = 1 | hdl = 10665/340684 | hdl-access = free | author-link = World Health Organization }} and the United States Adopted Name.{{cite web | title=Revakinagene taroretcel | website=AMA Finder | url=https://searchusan.ama-assn.org/finder/usan/search/LM-47/relevant/1/ | access-date=7 March 2025}}
References
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External links
- {{ClinicalTrialsGov|NCT03316300|A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A}}
- {{ClinicalTrialsGov|NCT03319849|A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol B}}
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