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Leqvio FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 18, 2025.

FDA Approved: Yes (First approved December 22, 2021)
Brand name: Leqvio
Generic name: inclisiran
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: High Cholesterol, Familial Heterozygous

Leqvio (inclisiran) is a small interfering RNA (siRNA) directed to PCSK9 (proprotein convertase subtilisin kexin type 9) mRNA used to reduce low-density lipoprotein cholesterol (LDL-C).

Development timeline for Leqvio

DateArticle
Jul 31, 2025Approval Novartis' Twice-Yearly Leqvio (inclisiran) Receives FDA Approval for New Indication Enabling First-Line Use
Jul 10, 2023Approval US FDA Approves Expanded Indication for Leqvio (inclisiran) to Include Treatment of Adults with High LDL-C and Who Are At Increased Risk of Heart Disease
Dec 22, 2021Approval FDA Approves Leqvio (inclisiran), First-in-Class siRNA to Reduce Low-Density Lipoprotein Cholesterol (LDL-C)
Nov 13, 2020New Novartis Analyses for Investigational Inclisiran Demonstrate Consistently Effective and Sustained LDL-C Reduction at Month 17, Regardless of Age and Gender
Aug 30, 2020Novartis New Analysis Shows High Consistency In Lowering LDL-C in Individual Response With Investigational Inclisiran
Mar 28, 2020Novartis New Analysis Further Shows Durable and Potent LDL-C Reduction with Inclisiran, an Investigational First-in-Class siRNA Cholesterol-Lowering Treatment
Mar 18, 2020Novartis Announces NEJM Publication of Three Pivotal Trials Showing Durable and Potent Efficacy of Inclisiran, an Investigational First-in-Class siRNA Cholesterol-Lowering Therapy
Nov 29, 2019The Medicines Company Announces that the ORION-9 Study of Inclisiran in HeFH Patients Showed Durable and Potent LDL-C Lowering with Twice-Yearly Dosing
Sep 25, 2019The Medicines Company Announces Positive Topline Results for ORION-9 Phase 3 Study of Inclisiran in Heterozygous Familial Hypercholesterolemia Patients
Nov  6, 2017The Medicines Company and Alnylam Pharmaceuticals Announce Initiation of Phase III Clinical Trials of Inclisiran
Aug 28, 2017New, One-Year Data from ORION-1 Phase II Study of Inclisiran Extends Excellent Long-Term Efficacy and Safety Profile, Affirming Dose for Phase III Trials

See also

Leqvio (inclisiran) Consumer information

Further information

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