Lerodalcibep

LEQVIO marks a significant advancement in hypercholesterolemia management, particularly for patients not achieving target LDL-C levels despite maximally tolerated statin therapy. As the first FDA-approved siRNA therapy for LDL-C reduction, it introduces a novel mechanism of action with sustained efficacy and biannual dosing, enhancing patient adherence. LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's " LEQVIO Market Size, Forecast, and Market Insight Report" highlights the details around LEQVIO, which is a PCSK9 Inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LEQVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Novartis/Alnylam Pharmaceuticals' LEQVIO (inclisiran) Overview 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 USD 2.2 billion in the US. Learn more about LEQVIO projected market size for PCSK9 inhibitors @ LEQVIO Market Potential 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 640,000 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 USD 2 billion 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 @ PCSK9 Inhibitors Market Report Emerging Competitors of LEQVIO Several drugs are currently under development in the PCSK9 inhibitor pipeline, including Lerodalcibep (LIB Therapeutics), MK-0616 (Merck), VERVE-101 and VERVE-102 (Verve Therapeutics), and CiVi 008 (CiVi Biopharma), among others. Lerodalcibep 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. MK-0616, 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. Verve Therapeutics is advancing two gene-editing candidates— VERVE-101 and VERVE-102—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 @ LEQVIO Market Positioning Compared to Other Drugs Key Milestones of LEQVIO In July 2023, the US FDA approved an expanded indication for Novartis LEQVIO to include treatment of adults with high LDL-C and who are at increased risk of heart disease. The updated indication for primary hyperlipidemia allows for the expanded use of LEQVIO as an adjunct to diet and statin therapy beyond the previously approved ASCVD and HeFH patient populations. In 2023, LEQVIO (inclisiran) was approved by MHLW for familial and non-familial hypercholesterolemia and for patients who are at a high risk of developing cardiovascular events. In August 2022, Novartis selected Soleo Health as a Limited Drug Distribution Partner for the Administration of LEQVIO. Under this partnership, Soleo Health will administer the drug to patients in their homes or at one of the Company's Ambulatory Infusion Centers (AICs) in the US. In 2021, Novartis reached an agreement with the National Health Service (NHS) in England to implement a first-of-its-kind population health management approach designed to provide faster and broader access to LEQVIO for certain high-risk patients with ASCVD. In December 2020, Novartis announced that the European Commission (EC) approved LEQVIO to treat adults with hypercholesterolemia or mixed dyslipidemia, two common forms of elevated cholesterol. Discover how LEQVIO is shaping the PCSK9 inhibitors treatment landscape @ LEQVIO Injection LEQVIO Market Dynamics LEQVIO, as a first-in-class small interfering RNA (siRNA) that helps maintain bad cholesterol levels and improve mortality rates, strengthens its market position with a value-based price per dose and promising market access and reimbursement. Ongoing trials for CVRR and Pediatric Hyperlipidemia expansion pave the way for label expansion, addressing diverse medical needs. The escalating patient population presents a favorable trend for expanding LEQVIO's market reach and driving growth. However, its market is currently constrained by its specific indication for HeFH in adults, potentially limiting its reach compared to competitors like REPATHA and PRALUENT, which are approved for both HoHF and HeHF in adults and pediatrics. The market is expected to face heightened competition post-2027, which may impact LEQVIO's market share, and similar annual treatment costs across PCSK9 inhibitors 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 @ LEQVIO Market Drug Report Table of Contents Related Reports PCSK9 Inhibitor Market PCSK9 Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 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 LIB Therapeutics, Merck, Verve Therapeutics, CiVi Biopharma, among others. PCSK9 Inhibitors Pipeline PCSK9 Inhibitors Pipeline Insight – 2025 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 Ionis Pharmaceuticals, Akeso Biopharma, Amgen, Novo Nordisk, Civi BioPharma, among others. Hypercholesterolemia Market Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 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 Novartis Pharmaceuticals, Merck Sharp & Dohme LLC, Esperion Therapeutics, Inc., Arrowhead Pharmaceuticals, LIB Therapeutics LLC, Medpace, Inc., AstraZeneca, NewAmsterdam Pharma, among others. Homozygous Familial Hypercholesterolemia Market Homozygous Familial Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 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 Arrowhead Pharmaceuticals, Novartis, Alnylam Pharmaceuticals, LIB Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep (LeroChol®), a novel, monthly, small dose third-generation PCSK9 inhibitor today announced results presented at the May 5-7 2025 European Atherosclerosis Society meeting in Glasgow. Pool Time Point Lero/Pbo N in group % LDL-C change* Absolute LDL-C* Total MACE# events: Pbo/Lero % (N) Odds Ratio (95% CI) p value Hazard Ratio (95% CI) p value Pool 1 Week 24 1547/771 -58.6% -67 mg/dL 1.7% (13) 0.7% (11) 0.418 (0.186-0.936) p<0.01 0.422 (0.189-0.943) p<0.01 Pool 2 Week 52 1229/612 -59.0% -65 mg/dL 4.1% (25) 2.2% (27) 0.527 (0.303-0.917) p<0.01 0.540 (0.313-0.930) p<0.01 *placebo adjusted mITT analysis; #MACE = composite of death, resuscitated cardiac arrest, acute myocardial infarction (STEMI and NSTEMI), hospitalization for unstable angina, stroke and coronary revascularization “We are very pleased and encouraged by the results from the pooled key registration trials, which were large, of long duration, and placebo-controlled,” said Dr. David Kallend, Chief Medical Officer of LIB Therapeutics. “The data demonstrates substantial and durable reductions in LDL-C - both in absolute terms and percentage change - as well as in other atherogenic lipoproteins such as Lp(a) and ApoB.” He continued, “Lerodalcibep was well tolerated with no safety concerns or drug-drug interactions, especially important for patients with CVD already on multiple other oral therapeutic agents. Its patient-friendly profile, including the only monthly, 12 doses per year, single small-volume SC injection which along with long-term ambient stability not requiring refrigeration by patients, makes it especially well-suited for patients with CVD or at high-risk for CVD, including those with FH, to help them achieve the new, more aggressive LDL-C targets and maintain life long adherence to therapy.” “While the number of CV events in the pooled phase trials was limited, the early, large, and statistically significant reductions in MACE are highly encouraging. We look forward to initiating a differentiated cardiovascular outcomes trial to further explore and confirm these findings.” About Lerodalcibep Lerodalcibep is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly, single small-volume, subcutaneous injection that will not require refrigeration at home or in travel. These features make Lerodalcibep a unique alternative to approved PCSK9 inhibitors. The anti-PCSK9 binding domain of Lerodalcibep is an 11-kDa polypeptide called an adnectin, engineered for high-affinity subnanomolar binding to human PCSK9 and fused to human serum albumin to enhance plasma half-life. In clinical trials, Lerodalcibep has demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very-high or high risk of, cardiovascular disease (CVD) and ≥50% in those with heterozygous familial hypercholesterolemia (FH) who have more severe LDL-C elevations, and is expected to expand treatment options for the millions of patients around the world with CVD, including the 30 million individuals with FH. The global Phase 3 LIBerate program enrolled a diverse population of over 2,900 patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia. Lerodalcibep was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients have continued in the 72-week open-label extension trial. Following the FDA BLA submission, LIB is preparing a Marketing Authorization Application to the European Medicines Agency. LIB submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in December 2024, and received formal filing by FDA in February with and anticipated PDUFA date in mid Dec this year. LIB is seeking approval of lerodalcibep to reduce LDL-C for the treatment of patients with atherosclerotic cardiovascular disease (ASCVD), or very high or high risk of ASCVD, and primary hyperlipidemia, including heterozygous and homozygous familial hypercholesterolemia (HeFH / HoFH). About LIB Therapeutics Inc. LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing Lerodalcibep to the millions of patients with cardiovascular disease and to the 30 million individuals with familial hypercholesterolemia (FH) around the world, who require additional large reductions in LDL-C, despite maximally tolerated statins and other lipid lowering agents, to achieve LDL-C goals. For more information, please visit: www.libtherapeutics.com.