Novartis (NVS) announced that the U.S. FDA has approved a label update for Leqvio, enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol 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.
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