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Inclisiran: First Approval

Inclisiran (Leqvio(®); Novartis) is a first-in-class, cholesterol-lowering small interfering RNA (siRNA) conjugated to triantennary N-acetylgalactosamine carbohydrates (GalNAc). Inclisiran received its first approval in December 2020 in the EU for use in adults with primary hypercholesterolaemia (he...

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Autor principal: Lamb, Yvette N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900795/
https://www.ncbi.nlm.nih.gov/pubmed/33620677
http://dx.doi.org/10.1007/s40265-021-01473-6
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author Lamb, Yvette N.
author_facet Lamb, Yvette N.
author_sort Lamb, Yvette N.
collection PubMed
description Inclisiran (Leqvio(®); Novartis) is a first-in-class, cholesterol-lowering small interfering RNA (siRNA) conjugated to triantennary N-acetylgalactosamine carbohydrates (GalNAc). Inclisiran received its first approval in December 2020 in the EU for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet. It is intended for use in combination with a statin or a statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol goals with the maximum tolerated statin dose. In patients who are statin-intolerant or for whom a statin is contraindicated, inclisiran can be used alone or in combination with other lipid-lowering therapies. Inclisiran is administered as a twice-yearly subcutaneous injection. This article summarizes the milestones in the development of inclisiran leading to this first approval for primary hypercholesterolaemia or mixed dyslipidaemia.
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spelling pubmed-79007952021-02-23 Inclisiran: First Approval Lamb, Yvette N. Drugs AdisInsight Report Inclisiran (Leqvio(®); Novartis) is a first-in-class, cholesterol-lowering small interfering RNA (siRNA) conjugated to triantennary N-acetylgalactosamine carbohydrates (GalNAc). Inclisiran received its first approval in December 2020 in the EU for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet. It is intended for use in combination with a statin or a statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol goals with the maximum tolerated statin dose. In patients who are statin-intolerant or for whom a statin is contraindicated, inclisiran can be used alone or in combination with other lipid-lowering therapies. Inclisiran is administered as a twice-yearly subcutaneous injection. This article summarizes the milestones in the development of inclisiran leading to this first approval for primary hypercholesterolaemia or mixed dyslipidaemia. Springer International Publishing 2021-02-23 2021 /pmc/articles/PMC7900795/ /pubmed/33620677 http://dx.doi.org/10.1007/s40265-021-01473-6 Text en © Springer Nature 2021, corrected publication 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle AdisInsight Report
Lamb, Yvette N.
Inclisiran: First Approval
title Inclisiran: First Approval
title_full Inclisiran: First Approval
title_fullStr Inclisiran: First Approval
title_full_unstemmed Inclisiran: First Approval
title_short Inclisiran: First Approval
title_sort inclisiran: first approval
topic AdisInsight Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7900795/
https://www.ncbi.nlm.nih.gov/pubmed/33620677
http://dx.doi.org/10.1007/s40265-021-01473-6
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