LIB Therapeutics has scored an FDA approval for its cholesterol-lowering, third-generation PCSK9 inhibitor, lerodalcibep-liga.
The injected treatment, which will carry the commercial name Lerochol, is approved to be used along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
Lerochol arrives on the market with a convenience edge over other PCSK9 drugs, as it is self-administered once monthly and doesn’t need refrigeration because it retains its stability for up to three months at room temperature. By comparison, Amgen’s Repatha and Sanofi and Regeneron’s Praluent are dosed between every two to four weeks, depending on patient needs, and have a shorter shelf life at room temperature.Lerochol is the first approved product for the privately held biotech, which is based in Cincinnati and was established in 2015 with assets gained from Bristol Myers Squibb. LIB expects to launch Lerochol in the second quarter of next year in a pre-filled syringe, with an upgraded autoinjector device coming before the end of 2026.
“We founded LIB Therapeutics with a mission to bring an effective and more patient-friendly treatment option to the millions of patients who still need additional LDL-C reduction in order to achieve the lower targets recommended in recent guidelines,” Evan Stein, M.D., Ph.D., the founder, CEO and chief scientific officer of LIB, said in a release. “Lerochol was designed for patients who need life-long treatment to achieve and maintain the new lower LDL-C goals, especially those with cardiovascular disease and the millions with inherited high cholesterol.”
The European Medicines Agency (EMA) is reviewing a marketing authorization application for Lerochol, with the company expecting approval there in June of 2026. Additional regulatory submissions in other markets worldwide are also under review, LIB said.
The U.S. approval is based on data from a trial program which tested 2,900 patients who were already receiving cholesterol-lowering treatments. Dosed monthly for 52 weeks, Lerochol showed sustained LDL-C reductions of more than 60% in patients with cardiovascular disease (CVD) or those at risk of developing CVD. In those with HeFH, Lerochol showed sustained LDL-C reductions of more than 50%.