European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) Closes July 20-23, 2026 Meeting With a Recommendation for EU Marketing Authorisation of Lyrokaul (Lerodalcibep), a Once-Monthly Self-Administered Subcutaneous Third-Generation PCSK9 Inhibitor Fusion Protein, for Adult Primary Hypercholesterolaemia and Mixed Dyslipidaemia With 59-65% Placebo-Adjusted LDL-C Reductions From the Phase 3 LIBerate-HeFH Registrational Trial in Adults With Heterozygous Familial Hypercholesterolaemia on Maximally Tolerated Statin Therapy; European Commission Marketing Authorisation Decision Typically Follows 2-3 Months
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) closed its July 20-23, 2026 meeting with a recommendation for EU marketing authorisation of Lyrokaul (lerodalcibep). Lerodalcibep is a third-generation PCSK9 inhibitor administered as a once-monthly self-administered subcutaneous injection. The active substance is an adnectin-Fc fusion protein that binds proprotein convertase subtilisin/kexin type 9 (PCSK9), preventing PCSK9-mediated degradation of LDL receptors in the liver and enhancing LDL-C clearance from circulation. In the Phase 3 LIBerate-HeFH registrational trial, adults with heterozygous familial hypercholesterolaemia (HeFH) on maximally tolerated statin therapy achieved placebo-adjusted LDL-C reductions of roughly 59-65% by Week 24, with approximately two-thirds of participants reaching European Society of Cardiology-recommended targets. The CHMP recommendation covers use in addition to diet, alone or in combination with other lipid-lowering therapies. European Commission marketing authorisation decisions typically follow CHMP recommendations by 2-3 months. Lerodalcibep received US FDA approval earlier in 2026 under the brand name Lerochol. The EU authorization would add a third-generation PCSK9 modality alongside injectable antibodies (Repatha/evolocumab, Praluent/alirocumab), the siRNA (Leqvio/inclisiran), and the oral macrocyclic peptide (LIPFENDRA/enlicitide, US-only as of July 25, 2026).