Leqvio FDA Approval History

Last updated by Judith Stewart, BPharm on July 18, 2023.

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).

Leqvio is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C).
Leqvio is administered via subcutaneous injection every six months, after the initial dose and another dose at three months.
Common adverse reactions include injection site reaction, arthralgia, urinary tract infection, diarrhea, bronchitis, pain in extremity, and dyspnea.

Development timeline for Leqvio

Date	Article
Jul 10, 2023	Approval 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, 2021	Approval FDA Approves Leqvio (inclisiran), First-in-Class siRNA to Reduce Low-Density Lipoprotein Cholesterol (LDL-C)
Nov 13, 2020	New Novartis Analyses for Investigational Inclisiran Demonstrate Consistently Effective and Sustained LDL-C Reduction at Month 17, Regardless of Age and Gender
Aug 30, 2020	Novartis New Analysis Shows High Consistency In Lowering LDL-C in Individual Response With Investigational Inclisiran
Mar 28, 2020	Novartis New Analysis Further Shows Durable and Potent LDL-C Reduction with Inclisiran, an Investigational First-in-Class siRNA Cholesterol-Lowering Treatment
Mar 18, 2020	Novartis 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, 2019	The 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, 2019	The Medicines Company Announces Positive Topline Results for ORION-9 Phase 3 Study of Inclisiran in Heterozygous Familial Hypercholesterolemia Patients
Nov 6, 2017	The Medicines Company and Alnylam Pharmaceuticals Announce Initiation of Phase III Clinical Trials of Inclisiran
Aug 28, 2017	New, 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

Further information

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Leqvio FDA Approval History

Development timeline for Leqvio

See also

Further information