Lerodalcibep-Liga Autoinjector Approved for Reduction of Major Adverse Cardiovascular Events

The FDA has approved an autoinjector device for lerodalcibep-liga (Lerochol; LIB therapeutics), a third-generation PCSK9 inhibitor, alongside an updated indication statement reflecting the established link between low-density lipoprotein cholesterol (LDL-C) reduction and decreased risk of major adverse cardiovascular events (MACE). The autoinjector is expected to be available in the US by January 2027 at the same $199-per-month direct-to-patient cash price as the existing prefilled syringe. Lerodalcibep-liga was first approved in December 2025 as an adjunct to diet and exercise for lowering LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).^1,2