Inclisiran

Inclisiran
Clinical data
Trade namesLeqvio
Other namesALN-PCSsc, ALN-60212
AHFS/Drugs.comMonograph
MedlinePlusa622009
License data
Pregnancy
category
Routes of
administration		Subcutaneous
Drug classAntilipemic agent
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
ChEBI
Chemical and physical data
FormulaC529H664F12N176O316P43S6
Molar mass16296.26 g·mol−1

Inclisiran, sold under the brand name Leqvio, is a medication used for the treatment of high low-density lipoprotein (LDL) cholesterol and for the treatment of people with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk-equivalents, and heterozygous familial hypercholesterolemia (HeFH).[5][7][6][9] It is a small interfering RNA (siRNA) that acts as an inhibitor of a proprotein convertase, specifically, inhibiting translation of the protein PCSK9.[10]

Inclisiran was approved for use in the European Union in December 2020.[7] In August 2021, it received NICE approval for use by the National Health Service in the UK.[11] In December 2021, it was approved for medical use in the United States.[6][9][12] The U.S. Food and Drug Administration considers it to be a first-in-class medication.[13] In August 2023, the National Medical Products Administration approved the use of inclisiran in China.[14]

  1. ^ a b "Leqvio". Therapeutic Goods Administration (TGA). 22 September 2021. Archived from the original on 30 September 2021. Retrieved 30 September 2021.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 12 May 2022. Archived from the original on 3 April 2022. Retrieved 13 May 2022.
  3. ^ "Summary Basis of Decision (SBD) for Leqvio". Health Canada. 23 October 2014. Archived from the original on 29 May 2022. Retrieved 29 May 2022.
  4. ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
  5. ^ a b "Leqvio- inclisiran injection, solution". DailyMed. Archived from the original on 28 December 2021. Retrieved 27 December 2021.
  6. ^ a b c "FDA approves add-on therapy to lower cholesterol among certain high-risk adults". U.S. Food and Drug Administration (FDA). 22 December 2021. Archived from the original on 24 December 2021. Retrieved 24 December 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ a b c "Leqvio EPAR". European Medicines Agency. 13 October 2020. Archived from the original on 8 January 2021. Retrieved 6 January 2021. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. ^ "Leqvio Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  9. ^ a b "Drug Trials Snapshots: Leqvio". U.S. Food and Drug Administration (FDA). 22 December 2021. Archived from the original on 28 July 2023. Retrieved 28 July 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ Cite error: The named reference FitzgeraldNEJM201701 was invoked but never defined (see the help page).
  11. ^ "Novartis signs deal with Britain's NHS for new cholesterol drug Leqvio". Reuters. 1 September 2021. Archived from the original on 1 September 2021. Retrieved 1 September 2021.
  12. ^ "FDA approves Novartis Leqvio (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year". Novartis (Press release). 22 December 2021. Retrieved 24 December 2021.
  13. ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  14. ^ "Novartis Gains China Approval for Pioneering Cholesterol Drug". www.yicaiglobal.com. Archived from the original on 24 August 2023. Retrieved 24 August 2023.