FDA Approves New Indication for Novartis’ Leqvio

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Expansion to include treatment for LDL-C reduction in patients with primary hyperlipidemia.

Novartis revealed that the FDA has approved a label update for Leqvio, providing earlier support to patients with elevated LDL-C who have an increased risk of heart disease as an addition to dieting. According to the company, patients include those with hypertension and diabetes that have not experienced a cardiovascular event.


First approved by the FDA in 2021, Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C.

"Novartis is committed to addressing the rising burden of cardiovascular disease, a substantial public health burden affecting 30 million Americans," said Victor Bulto, President of Novartis Innovative Medicines US. "High LDL-C is one of the most readily modifiable risk factors for heart disease and this label update for Leqvio will help us reach a greater number of patients who struggle with lowering their LDL-C."

Reference: US FDA approves expanded indication for Novartis Leqvio® (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease. PR Newswire. July 10, 2023. Accessed July 11, 2023. https://www.prnewswire.com/news-releases/us-fda-approves-expanded-indication-for-novartis-leqvio-inclisiran-to-include-treatment-of-adults-with-high-ldl-c-and-who-are-at-increased-risk-of-heart-disease-301872495.html