Swiss pharmaceutical company Novartis Pharma AG (SIX:NOVN) (NYSE:NVS) announced on Thursday that the US Food and Drug Administration (FDA) has approved a label update for Leqvio (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia.

The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies.

The updated label removes the requirement for Leqvio to be used on top of or in combination with statin therapy. Other updates include revising 'primary hyperlipidemia' to the more specific term of 'hypercholesterolemia' throughout the label, to more accurately focus on LDL-C reduction.

Leqvio is an injectable prescription medicine indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).

Novartis has obtained global rights to develop, manufacture and commercialise Leqvio under a license and collaboration agreement with RNAi therapeutics specialist Alnylam Pharmaceuticals.