FDA Approves Expanded Use for Novartis' Leqvio

Novartis said regulators have approved an expanded indication for its cholesterol drug Leqvio.

The Swiss pharma giant said Monday that the U.S. Food and Drug Administration approved a label update for Leqvio that allows for earlier use by patients with elevated low-density lipoprotein, or "bad," cholesterol who have an increased risk of heart disease.

The expanded indication for primary hyperlipidemia enables broader use of the drug beyond the previously approved atherosclerotic cardiovascular disease and heterozygous familial hypercholesterolemia patient populations, Novartis said.

The expansion is effective immediately in the U.S.

Novartis said the FDA's approval underscores the robust safety and effectiveness data for Leqvio.

https://www.morningstar.com/news/dow-jones/202307103934/fda-approves-expanded-use-for-novartis-leqvio