PCSK9 antibodies proved that deep LDL lowering was achievable, but fortnightly injections and payer resistance limited their reach. Leqvio (inclisiran) changed the dosing interval dramatically.
Unlike PCSK9 antibodies that bind the circulating protein, Leqvio silences PCSK9 messenger RNA inside the liver, which is why a subcutaneous injection twice yearly suffices after two starter doses. It is approved as add-on therapy for adults with heterozygous familial hypercholesterolemia or atherosclerotic cardiovascular disease.
Twice-yearly dosing lets Leqvio be administered in-office, shifting it toward a buy-and-bill model that differentiates it from self-injected competitors. It faces no generic competition, and cardiovascular outcomes data remain the key catalyst for broader guideline adoption.