European Commission expands Leqvio authorization to adolescents

The European Commission has expanded the EU authorization for the drug Leqvio (inclisiran) to include children and adolescents aged 12 and older with heterozygous familial hypercholesterolemia.

The decision, based on opinions from the Committee for Medicinal Products for Human Use, allows the medication to be used as an adjunct to statins or other lipid-lowering therapies for patients who cannot reach target LDL cholesterol levels with maximum tolerated statin doses, or for those who are intolerant to statins.

The dosage and administration schedule remain unchanged from the adult protocol: a single 284 mg subcutaneous injection, repeated after three months, and subsequently every six months. No separate dosage has been established for younger patients due to a lack of data regarding safety and efficacy in children under 12.