U.S. Food and Drug Administration Approves an Autoinjector Version of LEROCHOL® (lerodalcibep-liga) and Updated Indication

FDA approves autoinjector for third-generation cholesterol drug

Lerochol (lerodalcibep-liga) can be stored at room temperature for up to three months, helping it stand out compared to other PCSK9 inhibitors on the market. The FDA also approved updated labeling that emphasizes the drug's cardiovascular benefits.

U.S. Food and Drug Administration Approves an Autoinjector Version of LEROCHOL® (lerodalcibep-liga) and Updated Indication

CINCINNATI--(BUSINESS WIRE)--Aug 17, 2026-

FDA Approves An Autoinjector Version Of LEROCHOL® (lerodalcibep-liga) And Updated Indication

FDA also approved a positive update to the LEROCHOL indication statement reflecting the well-recognized reduction of risk for major adverse cardiovascular events achieved in adults via LDL-C lowering when treated with statins or with monoclonal antibody PCSK9 inhibitors used as an add-on to statin therapy The post FDA Approves an Autoinjector Version of LEROCHOL® (lerodalcibep-liga) and Updated Indication first appeared on Medical Device News Ma…