Leqvio FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 27, 2021.
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.
- Leqvio is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of lowdensity 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 |
|---|
| 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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