LEQVIO Sales Surge Globally, Driven by Rising Cardiovascular Risk Awareness and Demand for Long-Acting LDL-C Lowering Therapies

DelveInsight's "LEQVIO Market Size, Forecast, and Market Insight Report" delivers a comprehensive analysis of LEQVIO's commercial performance, competitive positioning, and future outlook across key global markets. Developed by Novartis, LEQVIO (inclisiran) is a first-in-class small interfering RNA (siRNA) therapy approved for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, particularly in patients who require additional LDL-C lowering despite statin therapy.

The report provides detailed insights into LEQVIO's mechanism of action, which targets PCSK9 synthesis in the liver, as well as its regulatory milestones, clinical trial landscape, and market uptake trends. It also features historical and projected sales data from 2019 to 2032 across the 7MM [United States, EU4 (Germany, France, Italy, Spain), United Kingdom, and Japan], highlighting its evolving role in the lipid-lowering therapy market.

Learn more about LEQVIO's sales and market ground here: https://www.delveinsight.com/report-store/leqvio-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

LEQVIO (inclisiran) Overview
LEQVIO (inclisiran, KJX839) is the first and only small interfering RNA (siRNA) therapy developed by Novartis to lower low-density lipoprotein cholesterol (LDL-C) through a novel RNA interference (RNAi) mechanism. Designed to support patients with atherosclerotic cardiovascular disease (ASCVD)-a leading cause of mortality-LEQVIO offers sustained LDL-C reduction with just two doses per year, complementing standard statin therapy.

Unlike traditional lipid-lowering treatments, LEQVIO works at the source by reducing the production of the PCSK9 protein in the liver. This enhances the liver's ability to remove LDL-C from the bloodstream, helping to maintain long-term control over cholesterol levels.

Inclisiran is a synthetic, long-acting siRNA conjugated to triantennary N-acetylgalactosamine (GalNAc) carbohydrates, which enable targeted delivery to hepatocytes via binding to asialoglycoprotein receptors. Once inside liver cells, the siRNA integrates into the RNA-induced silencing complex (RISC), guiding the complex to degrade PCSK9 mRNA and thus suppress PCSK9 protein synthesis.
This precise gene-silencing mechanism enables robust and specific LDL-C reduction while avoiding activation of the mammalian interferon response. Originally developed by The Medicines Company, LEQVIO became part of Novartis' portfolio following the company's acquisition and is being developed and commercialized globally under a license agreement with Alnylam Pharmaceuticals.

Dosage and administration:
The recommended dosage of inclisiran is 284 mg, given as a single subcutaneous injection: once initially, again at three months, and then every six months thereafter. Inclisiran may be administered directly following the final dose of a monoclonal antibody PCSK9 inhibitor. To ensure continued LDL-C reduction, it is advised that inclisiran be administered within two weeks after the last dose of the PCSK9 monoclonal antibody

Drug Details:
Drug Name: LEQVIO (inclisiran)
Molecule Type: Small interfering RNA (siRNA)
Developer: Novartis (originally by The Medicines Company)
Approvals: Atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH) in adults requiring additional LDL-C lowering
Mechanism of Action: PCSK9 synthesis inhibitor via RNA interference (RNAi), reduces hepatic PCSK9 production to increase LDL-C clearance
Route of Administration: Subcutaneous (SC) injection (initial dose, then at 3 months, followed by every 6 months)

Learn more about LEQVIO's projected market size for ASCVD and hypercholesterolemia @ https://www.delveinsight.com/report-store/leqvio-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

LEQVIO for Hypercholesterolemia
Hypercholesterolemia is a condition marked by high blood cholesterol levels, particularly LDL-C ("bad" cholesterol), which significantly increases the risk of heart disease. According to the NIH, about 31.7% of U.S. adults have elevated LDL-C, with prevalence rising to 48.4% in those aged 65-74.

Treatment options include statins, bile-acid-binding resins, cholesterol absorption inhibitors, PCSK9 inhibitors, and injectable therapies. In December 2021, the FDA approved LEQVIO (inclisiran), an siRNA therapy, as an add-on to diet and statins for adults with heterozygous familial hypercholesterolemia (HeFH). It effectively lowers LDL-C levels through twice-yearly dosing.

Additionally, in February 2020, Esperion Therapeutics received FDA approval for NEXLETOL and NEXLIZET, oral therapies for HeFH or ASCVD patients needing further LDL-C reduction.

According to DelveInsight, the Hypercholesterolemia market across the 7MM is expected to undergo significant transformation from 2020 to 2034.

Discover more about the hypercholesterolemia market in detail @ https://www.delveinsight.com/report-store/hypercholesterolemia-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

LEQVIO for Atherosclerotic Cardiovascular Disease (ASCVD)
Atherosclerotic Cardiovascular Disease is a chronic condition affecting arteries in the heart, brain, and limbs, leading to conditions like coronary artery disease, stroke, and peripheral arterial disease. Major risk factors include poor diet, inactivity, smoking, obesity, alcohol use, and family history. In 2023, the U.S. had the highest diagnosed prevalence among the 7MM, with nearly 26 million cases- ~14 million males and ~11 million females- expected to rise by 2034.

ASCVD management includes lifestyle changes, pharmacotherapy, and invasive procedures like angioplasty or bypass surgery. A patient-centered approach assessing lifestyle and risk helps guide treatment decisions.

The ASCVD treatment market in the 7MM reached ~USD 23.3 billion in 2023 and is projected to grow. The U.S. led the market, accounting for around 52% of total sales.

Emerging Competitors of LEQVIO
Some of the drugs in the pipeline of ASCVD and hypercholesterolemia include Lerodalcibep: LIB Therapeutics, MK-0616: Merck Sharp & Dohme /UCB Pharmaceuticals, Olpasiran (AMG 890): Amgen Inc., Obicetrapib (TA-8995): NewAmsterdam Pharma, and others.

To know more about the number of competing drugs in development, visit @ https://www.delveinsight.com/report-store/leqvio-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Milestones of LEQVIO
• In October 2024, in its Q3 2024 financial report, Novartis highlighted that Leqvio (inclisiran) achieved a 119% year-over-year sales growth, contributing to the company's overall 10% net sales increase. This growth reflects the strong performance and increasing adoption of Leqvio in the market.
• In August 2024, Novartis announced that the Phase III V-MONO study of LEQVIO (inclisiran) met its primary endpoints. The study demonstrated that twice-yearly Leqvio significantly reduced low-density lipoprotein cholesterol (LDL-C) compared to placebo and ezetimibe in patients at low or moderate risk of atherosclerotic cardiovascular disease (ASCVD).
• In April 2024, Novartis announced that the Phase III V-INITIATE study demonstrated that early addition of twice-yearly LEQVIO (inclisiran) to maximally tolerated statin therapy significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) who could not reach their LDL-C goals with statin therapy alone. The study showed a 60% LDL-C reduction with LEQVIO compared to 7% with usual care. Additionally, a significantly greater proportion of patients receiving LEQVIO achieved guideline-recommended LDL-C goals while maintaining adherence to statin treatment. The safety profile of LEQVIO was consistent with previous studies.

Explore recent advancements in LEQVIO to stay informed with expert-level insights here: https://www.delveinsight.com/report-store/atherosclerotic-cardiovascular-disease-ascvd-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

LEQVIO Market Dynamics
LEQVIO® (inclisiran), developed by Novartis, is a first-in-class small interfering RNA (siRNA) therapy targeting PCSK9 to reduce LDL-C levels. Its novel mechanism-using RNA interference to inhibit PCSK9 synthesis in the liver-offers a durable LDL-C lowering effect with just two subcutaneous doses per year. This unique dosing schedule improves patient adherence compared to daily statins or biweekly PCSK9 monoclonal antibodies, making it a highly attractive option for long-term cardiovascular risk reduction, particularly in patients with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD).

The market potential for LEQVIO is strongly driven by the growing global burden of ASCVD and the need for innovative lipid-lowering therapies. Clinical trials such as ORION-10, ORION-11, and recent updates from the V-MONO study have demonstrated significant LDL-C reductions and consistent efficacy, reinforcing LEQVIO's clinical value. Additionally, updated guidelines from major cardiovascular societies and increasing healthcare provider awareness are fostering uptake in eligible patient populations, especially those not reaching LDL-C targets with statins alone.

However, LEQVIO's market growth faces challenges including high treatment costs, limited early reimbursement coverage in certain regions, and slow integration into existing treatment paradigms. Despite FDA and EMA approvals, uptake has been uneven, particularly where physician familiarity with siRNA technology is limited. Moreover, some payers remain cautious, awaiting long-term cardiovascular outcomes data to fully validate cost-effectiveness.

Looking ahead, Novartis is focused on expanding LEQVIO's use through ongoing studies targeting broader risk groups and primary prevention settings. With strategic investments in real-world evidence generation and global rollout efforts, LEQVIO is well-positioned to gain traction as a cornerstone therapy in lipid management, especially in high-risk populations inadequately served by current therapies.

Dive deeper to get more insight into LEQVIO's strengths & weaknesses relative to competitors @ https://www.delveinsight.com/report-store/leqvio-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Report Introduction
2. LEQVIO Overview
3. Competitive Landscape (Marketed Therapies)
4. Competitive Landscape (Late-stage Emerging Therapies)
5. LEQVIO Market Assessment
6. SWOT Analysis
7. Analysts' Views
8. Appendix
9. DelveInsight Capabilities
10. Disclaimer
11. About DelveInsight
12. Report Purchase Options

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About DelveInsight
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This release was published on openPR.