FDA approves expanded indication for PCSK9 siRNA for primary prevention

The FDA has approved expanded indication for inclisiran, enabling broader use of inclisiran in patients with primary hyperlipidemia with increased CV risk, but who have not had a CV event.

The US Food and Drug Administration (FDA) has approved a label update for inclisiran to include treatment of patients with elevated LDL-c who have an increased risk of heart disease, in addition to diet and statin therapy, for primary prevention of CV events.

Inclisiran was approved by the FDA in December 2021 to lower LDL-c in patients with atherosclerotic CVD and heterozygous FH.

Source: press release Novartis, July 10, 2023