LIB takes aim at cholesterol market with new PCSK9 option

Privately-held drug developer LIB Therapeutics has claimed FDA approval for a new once-monthly PCSK9 inhibitor – Lerochol – that can be used to reduce cholesterol levels.

The injectable product has been approved alongside diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).

According to Cincinnati-based LIB, Lerochol (lerodalcibep) is a 'third-generation' PCSK9 inhibitor that offers advantages over existing drugs in the class – including Amgen's Repatha (evolocumab) and Sanofi and Regeneron's Praluent (alirocumab) – including low injection volumes and no need for refrigeration with a room temperature shelf-life of up to three months.

According to LIB, that profile gives patients the freedom to administer the drug where and when they choose, and the company hopes that will give it an edge in the market over its rivals.

Repatha and Praluent are dosed every two or four weeks, depending on patient need, and have a shorter shelf-life at ambient temperatures. Tipped to become massive sellers when they first launched, the two products failed to live up to their early commercial promise.

Repatha has been the more successful, growing steadily to reach global sales of $2.2 billion last year, while Praluent made around $765 million. Since their launch more than a decade ago, newer PCSK9-targeting drugs have reached the market, including Novartis' twice-yearly RNAi therapy Leqvio (inclisiran), which claimed its first approvals in 2022 and brought in $754 million in 2024.

Another possible entrant that could disrupt the PCSK9 market is MSD's oral candidate enlicitide, which showed comparable efficacy to injectables in the CORALreef Lipids trial presented last month at the ASH congress. It is due to be filed for approval in the coming months. Meanwhile, AstraZeneca has another oral candidate called AZD0780 in phase 3 testing.

LIB plans to launch Lerochol – its first commercial product – in the second quarter of 2026, initially in a prefilled syringe formulation with an autoinjector pen due to be available before the end of the year. The drug is also under regulatory review in Europe, with approvals there due around the middle of next year. Analysts have previously suggested peak US sales could reach around $300 million a year.

The FDA approval of Lerochol is based on data from the global phase 3 LIBerate clinical trial programme, which showed that the drug achieved sustained LDL-C reductions of 60% or more in people with high cholesterol who were at very-high or high risk of cardiovascular disease, and 59% in those with HeFH who tend to have more severe LDL-C elevations.

"The primary challenge in lipid management today is helping patients achieve and maintain the increasingly stringent LDL-C targets in current guidelines," said Dean Kereiakes of the University of Cincinnati, a LIBerate investigator.

"While PCSK9 inhibitors as a class deliver powerful cholesterol-lowering potential, Lerochol was designed to address the barriers that have limited their use, including ease-of-use features," he added.

The approval is also good news for Shanghai-based Everest Medicines, which has exclusive rights to develop, register, and commercialise lerodalcibep in Greater China. It plans to file for approval with China's regulatory authority in the first half of next year, with an anticipated 2027 launch date.