US EditionNovartis twice-yearly* Leqvio® (inclisiran) receives FDA approval for new indication enabling first-line use
UNITED STATES, AUG 1 – The FDA updated Leqvio's label to allow use without statins, addressing that 80% of atherosclerotic cardiovascular disease patients in the US miss LDL cholesterol targets, officials said.
- The FDA approved a label update for Leqvio , enabling its use as monotherapy for LDL-C reduction in adults with hypercholesterolemia, said Victor Bult.
- The 2025 ACC/AHA guideline calls for more aggressive LDL-C lowering, and up to 80% of ASCVD patients in the US fail to reach <70 mg/dL, prompting the FDA to request the Leqvio label update.
- Victor Bult said, 'Leqvio's twice-yearly dosing supports adherence and long-term LDL-C management,' highlighting its benefits supported by FDA approval for new indication.
- In his statement, Victor Bult highlighted the update’s significance, saying it "reinforces Leqvio's proven ability to effectively lower LDL-C, a critical risk factor for heart disease," while Novartis noted its medicines reach nearly 300 million people worldwide.
- The press release states that Novartis emphasizes the need for sustained LDL-C management as ASCVD accounts for 85% of all cardiovascular deaths, and it contains forward-looking statements under the US Private Securities Litigation Reform Act of 1995.
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FDA approves inclisiran monotherapy for LDL lowering
Novartis announced the FDA approved updated labeling for inclisiran, a small-interfering RNA therapy, for use as monotherapy on top of diet and exercise to reduce LDL in adults with hypercholesterolemia. As Healio previously reported, the FDA approved inclisiran (Leqvio) for LDL lowering, administered once every 6 months after an initial dose and one at 3 months.
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