FDA accepts BLA for lerodalcibep for lowering LDL-cholesterol in patients with ASCVD

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LIB Therapeutics has announced that the FDA has accepted its biologics license application (BLA) for lerodalcibep, a treatment designed to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD) or those at high risk of developing the condition. The drug is also intended for patients with primary hyperlipidemia, including those with homozygous familial hypercholesterolemia as young as 10 years old.

Lerodalcibep is a third-generation PCSK9 inhibitor designed as a once-monthly, self-administered injection. According to the company, it provides a patient-friendly alternative to existing PCSK9 inhibitors by offering long-ambient stability and eliminating the need for refrigeration at home or during travel.

The FDA has set a Prescription Drug User Fee Act action date of December 12, 2025, for its review of lerodalcibep. Currently, the agency does not plan to hold an advisory committee meeting on the application.

Evan Stein, MD, PhD, FACC, co-founder and chief operating and scientific officer of LIB Therapeutics, highlighted the need for improved cholesterol-lowering treatments. “There remains a large unmet need among millions of patients with cardiovascular disease, or at high cardiovascular risk, including the 30 million people with inherited high cholesterol, who are unable to achieve currently recommended guideline-directed goals for LDL cholesterol with current oral therapies,” he said.

Stein also emphasized lerodalcibep’s effectiveness in clinical trials. “Lerodalcibep has demonstrated robust and sustained long-term LDL cholesterol-lowering, enabling the vast majority of patients to achieve these more stringent lower LDL-cholesterol targets with excellent safety and adherence across clinical trials,” he added.

LIB Therapeutics’ development program for lerodalcibep included 5 global Phase 3 registration studies under the LIBerate program, with data from 2,900 patients. More than 2,300 participants in these trials were already on maximally tolerated statins and other oral agents but required additional LDL cholesterol reduction.

David Cory, RPh, MBA, CEO of LIB Therapeutics, described lerodalcibep as “a potential best-in-class PCSK9 inhibitor with a once-monthly, single small-volume subcutaneous dose, combined with long ambient stability not requiring refrigeration at home or in travel, offering a more patient-friendly treatment option to achieve the new lower LDL-C goals.”

Cory also outlined the company’s commercial plans, stating, “The LIB operating team is now focused on lerodalcibep US commercial launch preparation. Lerodalcibep will enter a now rapidly growing global PCSK9 market on target to reach $5B in 2025 and projected to be $10B by 2030.”

LIB Therapeutics expects to submit a marketing authorization application to the European Medicines Agency in the second quarter of 2025.

Reference:

LIB Therapeutics. LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population. Business Newswire. February 10, 2025. Accessed February 10, 2025. https://www.businesswire.com/news/home/20250210806330/en/LIB-Therapeutics-Announces-FDA-Acceptance-of-Biologics-License-Application-for-Lerodalcibep-to-Lower-LDL-Cholesterol-Across-Broad-Patient-Population