Inclisiran

Inclisiran, sold under the brand name Leqvio, is a medication for the treatment of people with atherosclerotic cardiovascular disease (ASCVD), ASCVD risk equivalents and heterozygous familial hypercholesterolemia (HeFH). It is a small interfering RNA that inhibits translation of the protein PCSK9.[3][4][5] It is being developed by The Medicines Company which licensed the rights to inclisiran from Alnylam Pharmaceuticals.[6]

Inclisiran
Clinical data
Trade namesLeqvio
Other namesALN-PCSsc, ALN-60212
Pregnancy
category
Routes of
administration		Subcutaneous injection
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only) [1]
  • EU: Rx-only [2]
Identifiers
CAS Number
  • 1639324-58-5
DrugBank
UNII
KEGG
ChEBI
Chemical and physical data
FormulaC520H679F21N175O309P43S6
Molar mass16248.27 g·mol−1

On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Leqvio, intended for the treatment for primary hypercholesterolaemia or mixed dyslipidaemia.[7] Inclisiran was approved for use in the European Union in December 2020.[2] In August 2021 it received NICE approval for use by the National Health Service in the UK.[8]

History

In 2019 The Medicines Company announced positive results from pivotal phase III study (all primary and secondary endpoints were met with efficacy consistent with Phase I and II studies). The company anticipates regulatory submissions in the U.S. in the fourth quarter of 2019, and in Europe in the first quarter of 2020.[9] The Medicines Company is being acquired by Novartis.[10]

References
  1. "Leqvio". Therapeutic Goods Administration (TGA). 22 September 2021. Retrieved 30 September 2021.
  2. "Leqvio EPAR". European Medicines Agency. 13 October 2020. Retrieved 6 January 2021.
  3. Fitzgerald K, White S, Borodovsky A, Bettencourt BR, Strahs A, Clausen V, et al. (January 2017). "A Highly Durable RNAi Therapeutic Inhibitor of PCSK9". The New England Journal of Medicine. 376 (1): 41–51. doi:10.1056/NEJMoa1609243. PMC 5778873. PMID 27959715.
  4. Spreitzer H (11 September 2017). "Neue Wirkstoffe: Inclisiran". Österreichische Apotheker-Zeitung (in German) (19/2017).
  5. "Proposed INN: List 114" (PDF). WHO Drug Information. WHO. 29 (4): 531f. 2015.
  6. Taylor NP (26 August 2019). "Medicines Company's PCSK9 drug hits phase 3 efficacy goals". FierceBiotech.
  7. "Leqvio: Pending EC decision". European Medicines Agency (EMA). 16 October 2020. Retrieved 16 October 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. "Novartis signs deal with Britain's NHS for new cholesterol drug Leqvio". Reuters. 2021-09-01.
  9. "The Medicines Company Announces Positive Topline Results from First Pivotal Phase 3 Trial of Inclisiran". The Medicines Company. Retrieved 29 August 2019.
  10. "Novartis acquires medicines company". Novartis. Retrieved 15 January 2020.

Further reading
  • "Inclisiran". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03399370 for "Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)" at ClinicalTrials.gov
  • Clinical trial number NCT03400800 for "Inclisiran for Subjects With ACSVD or ACSVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol (ORION-11)" at ClinicalTrials.gov


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