FDA Clears Lerodalcibep-Liga Autoinjector and Expands LDL-C Indication for Hypercholesterolemia

The FDA has approved an autoinjector version of lerodalcibep-liga (Lerochol; Lib Therapeutics), a once-monthly PCSK9 inhibitor, and updated its label to link the drug's low-density lipoprotein cholesterol (LDL-C)–lowering ability to reduced cardiovascular risk. This third-generation PCSK9 inhibitor was initially approved in December 2025 as an adjunctive treatment for adults with hypercholesterolemia. The new autoinjector is designed for quick dosing and does not require refrigeration for up to 90 days.