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LEQVIO Strengthens Position as Leader in Cholesterol-Lowering Therapies Across Seven Major Markets | DelveInsight
LEQVIO (inclisiran) is a first-of-its-kind therapy developed by Novartis based on small interfering RNA (siRNA) technology. It targets the mRNA of PCSK9 (proprotein convertase subtilisin/kexin type 9), reducing the production of this protein in the liver. Unlike traditional treatments, LEQVIO lowers LDL-C levels by enhancing the liver's ability to absorb and eliminate it from the bloodstream.
In the US, LEQVIO is approved for use alongside diet and statin therapy in adults with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH), to help reduce low-density lipoprotein cholesterol (LDL-C).
The recommended LEQVIO dosage is 284 mg, given via subcutaneous injection initially, followed by a dose at 3 months, and then every 6 months thereafter, in combination with statins. In 2034, the market size of inclisiran is expected to be in the US.
Learn more about LEQVIO projected market size for PCSK9 inhibitors @
Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a serine protease essential to cholesterol metabolism, primarily by controlling the breakdown of low-density lipoprotein (LDL) receptors. This mechanism decreases the removal of LDL particles from the blood, thereby influencing LDL cholesterol (LDL-C) levels. There is an inverse relationship between PCSK9 activity and LDL-C levels: gain-of-function mutations in the PCSK9 gene lead to increased LDL-C and a higher cardiovascular risk, as seen in familial hypercholesterolemia, while loss-of-function mutations are associated with lower LDL-C levels and reduced atherosclerotic cardiovascular disease (ASCVD) risk. In 2023, approximately cases of familial hypercholesterolemia were diagnosed across the 7MM, with homozygous forms being extremely rare.
PCSK9 inhibitors have emerged as a vital therapeutic option for hypercholesterolemia management, especially for patients at elevated cardiovascular risk or those unresponsive to standard treatments like statins. These drugs inhibit PCSK9, a protein that promotes LDL receptor degradation. By blocking PCSK9, these therapies enhance the presence of LDL receptors on liver cells, improving LDL-C clearance from the bloodstream. According to DelveInsight, the PCSK9 inhibitor market in the 7MM was valued at in 2023.
In summary, the PCSK9 inhibitor market is projected to witness substantial growth, driven by their use in statin-intolerant patients, expanding applications of PCSK9 inhibition, potential in broader therapeutic areas, and their role in preventive strategies to help reduce the overall cardiovascular disease burden.
Discover more about the PCSK9 inhibitors market in detail @
Several drugs are currently under development in the PCSK9 inhibitor pipeline, including (LIB Therapeutics), (Merck), (Verve Therapeutics), and (CiVi Biopharma), among others.
is a third-generation PCSK9 inhibitor designed to overcome the limitations of traditional LDL-C-lowering therapies like statins and ezetimibe. It aims to help patients reach the more aggressive LDL-C targets recommended by recent cardiovascular guidelines. The drug is being developed as a once-monthly, low-volume injection with long shelf stability at room temperature. Currently in Phase III clinical trials, LIB Therapeutics intends to file a Biologics License Application (BLA) by year-end, with a potential PDUFA decision expected in the latter half of 2025.
, an oral PCSK9 inhibitor from Merck, is a novel macrocyclic peptide that blocks the interaction between PCSK9 and LDL receptors, thus reducing LDL cholesterol. It is currently in Phase III trials and could become the first oral treatment in its class.
is advancing two gene-editing candidates— —targeting PCSK9. These one-time treatments are designed to permanently switch off the PCSK9 gene in the liver, thereby lowering LDL-C levels. VERVE-102 is being evaluated in the Heart-2 Phase Ib trial for patients with heterozygous familial hypercholesterolemia (HeFH) or early-onset coronary artery disease. Meanwhile, enrollment in the Heart-1 trial for VERVE-101 has been paused due to lab abnormalities, and an investigation is ongoing. Based on the results, Verve will work with regulators to decide the next steps for VERVE-101. The company plans to initiate a randomized, placebo-controlled Phase II trial based on data from both the Heart-1 and Heart-2 studies.
As these next-generation therapies move closer to approval, they have the potential to significantly disrupt and redefine the PCSK9 inhibitor market, ultimately giving fierce competition to LEQVIO.
To know more about the number of competing drugs in development, visit @
Discover how LEQVIO is shaping the PCSK9 inhibitors treatment landscape @
LEQVIO, as a first-in-class that helps maintain bad cholesterol levels and improve mortality rates, strengthens its market position with a and promising market access and reimbursement. Ongoing trials for pave the way for label expansion, addressing diverse medical needs. The presents a favorable trend for expanding LEQVIO's market reach and driving growth.
However, its market is currently , potentially limiting its reach compared to competitors like , which are approved for both HoHF and HeHF in adults and pediatrics. The market is expected to face , which may impact LEQVIO's market share, and similar may pose a challenge, affecting LEQVIO's competitive edge despite better reimbursement policies.
Dive deeper to get more insight into LEQVIO's strengths & weaknesses relative to competitors @
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PCSK9 inhibitor companies, including among others.
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PCSK9 inhibitors companies, including among others.
report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hypercholesterolemia companies, including among others.
report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key homozygous familial hypercholesterolemia companies, including among others.
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Shruti Thakur
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