Lerodalcibep

CINCINNATI--(BUSINESS WIRE)--LIB Therapeutics, Inc. (LIB), a privately held biopharmaceutical company with a singular focus on helping high-risk patients achieve their cholesterol goals, today announced the U.S. Food and Drug Administration (FDA) has approved an autoinjector for LEROCHOL® (lerodalcibep-liga) Injection 300 mg/1.2 mL, a third-generation Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor that combines robust and sustained efficacy with once-monthly, single injection self-administration to support long-term adherence. The FDA also approved an update to the LEROCHOL indication statement in its prescribing information reflecting the reduction of risk for major adverse cardiovascular events (MACE) achieved in adults via LDL-C lowering with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy. “Numerous clinical trials over nearly 40 years have repeatedly established that lowering LDL cholesterol with statins and, more recently, with PCSK9 inhibitors when added to statins, further lowers the risk of major cardiovascular events, and we’re pleased that FDA has added labeling across the PCSK9 class converging around that body of evidence,” said Evan Stein, M.D., Ph.D., Founder, CEO and Chief Scientific Officer of LIB Therapeutics. “These studies have resulted in worldwide consensus and alignment of guidelines on new lower targets, and greater additional reductions in LDL-C, for the millions of patients who cannot reach guideline-directed LDL-C goals on maximally tolerated statin therapy. The challenge now, with this newest class of very effective LDL-C lowering agents, is how to make them simple and affordable enough for patients, who must maintain them for what is life-long treatment. LEROCHOL was designed with a patient perspective in mind to achieve exactly that: a robust and sustained LDL-C reduction from a single, small monthly injection that patients self-administer, with room temperature storage of up to 90 days and now in a modern autoinjector device.” The FDA-approved autoinjector is an innovative, single-use device designed for quick, straightforward patient administration. It is pressure-activated with a single motion and delivers a complete dose in seconds. LEROCHOL in a pre-filled syringe remains available, giving patients and prescribers access to additional administration options. LEROCHOL is the first and only PCSK9 inhibitor that patients self-administer as a monthly, single injection, that can be stored at room temperature conditions for up to 90 days making it easily carried with patients on vacation or business travel. “Innovation in PCSK9 inhibition cannot stop at the molecule, because how a medicine for life-long therapy fits into a patient’s life is what determines whether they stick with it over the long haul,” said Kristen Miller, Vice President, Brand Communications, LIB Therapeutics. “The monthly dosing by autoinjector is completed in seconds, does not interfere with any oral medications, require overnight fasting, or limit the timing of food and beverage consumption. These features, along with the extended room temperature storage, mean LEROCHOL fits into patients’ lives and not the other way around.” “PCSK9 inhibitors have been one of the most important advances in cardiovascular medicine of the last 20 years. However, a patient only gets benefit from the lower and sustained LDL-C levels these medications provide if they stay on treatment,” said Dean J. Kereiakes, M.D., FACC, MSCAI, Chairman of The Christ Hospital Heart and Vascular Institute and Professor of Medicine at the University of Cincinnati. “As much as patients expect highly efficacious and safe therapies, they need therapies that fit into their busy lifestyles, and LEROCHOL provides a compelling option on both counts. LEROCHOL provides substantial LDL-C reduction that achieves the 2026 lipid guidelines in the vast majority of my patients with minimal inconvenience. My patients really appreciate having only once-monthly dosing with LEROCHOL, and now the availability of the autoinjector further simplifies this important treatment option.” LIB plans to make the LEROCHOL autoinjector available in the United States by January 2027. Insurance coverage of LEROCHOL is expected to expand gradually over the course of 2027, and when launched, the autoinjector of LEROCHOL will sit alongside the pre-filled syringe in the company’s direct-to-patient cash pay program for $199 per month. LIB will share additional details on the timing of autoinjector availability, access options, and patient support programs as those plans are finalized. LEROCHOL requires a prescription from a licensed healthcare provider. Patients and healthcare providers interested in LEROCHOL and the LEROCHOL DirectTM cash pay program are encouraged to visit www.LEROCHOL.com to learn more. IMPORTANT SAFETY INFORMATION Adverse Reactions The most commonly occurring adverse reactions in clinical trials in primary hyperlipidemia in adults (including heterozygous familial hypercholesterolemia [HeFH]) (≥2% of patients treated with LEROCHOL ® (lerodalcibep-liga) and occurring more frequently than with placebo) were nasopharyngitis (15% and 14% versus placebo), local injection site reactions (12% and 5% versus placebo) and peripheral edema (2% and <1% versus placebo). The most commonly occurring adverse reactions in clinical trials in HeFH (≥2% of patients treated with LEROCHOL and occurring more frequently than with placebo) were injection site reactions (18% and 3% versus placebo), nasopharyngitis (13% and 9% versus placebo), diarrhea (3% and 1% versus placebo), nausea (2% and 0% versus placebo) and peripheral edema (2% and <1% versus placebo). The most frequent adverse reaction leading to treatment discontinuation in trials in primary hypercholesterolemia in adults was injection site reactions, with a higher frequency in the LEROCHOL-treated group compared to placebo-treated patients (1% vs. 0%). Immunogenicity LEROCHOL is a recombinant fusion protein. As with all therapeutic proteins, there is potential for immunogenicity with LEROCHOL. INDICATIONS LEROCHOL® (lerodalcibep-liga) is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Cardiovascular outcomes trials have demonstrated that reducing LDL‑C lowers the risk for major adverse cardiovascular events (MACE) in adults at increased risk when treated with statins or monoclonal antibody PCSK9 inhibitors as an add-on to statin therapy. For full prescribing information, please visit www.LEROCHOL.com. About LEROCHOL® (lerodalcibep-liga) LEROCHOL is a novel, small protein-binding, third-generation PCSK9 inhibitor, and has been developed as a convenient, once-monthly, self-administered, single small-volume, subcutaneous injection with extended room temperature stability up to three months. These features make LEROCHOL a unique alternative to other PCSK9 inhibitors. The anti-PCSK9 binding domain of LEROCHOL 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. About the LIBerate Clinical Trial Program™ The FDA approval of LEROCHOL was based on data from the comprehensive global Phase 3 LIBerate Clinical Trial Program, which enrolled a diverse population of over 2,900 patients with cardiovascular disease (CVD), without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (HeFH). LEROCHOL was dosed once monthly for up to 52 weeks in these key registration-enabling, placebo-controlled trials, and over 2,400 patients continued in the 72-week open-label extension trial. In clinical trials, LEROCHOL demonstrated sustained LDL-C reductions of ≥60% in patients with, or at very high or high risk of, cardiovascular disease and ≥59% in those with HeFH who have more severe LDL-C elevations. LEROCHOL was generally well tolerated across the LIBerate Clinical Trial Program, with no serious treatment-related adverse events reported in the long-term extension studies. About LIB Therapeutics, Inc. LIB Therapeutics is a privately held, commercial-stage biopharmaceutical company dedicated to bringing novel, highly effective, and safe therapies to help the millions of patients with cardiovascular disease and familial hypercholesterolemia finally achieve their LDL-C goals. The company has also submitted a Marketing Authorization Application to the European Medicines Agency, with anticipated approval in 2H 2026. In Greater China, a Biologics License Application has been submitted, with potential approval in 2027. LIB is pursuing additional regulatory submissions in other markets worldwide. For more information, please visit: www.libtherapeutics.com.