Novartis Announces That The U.S FDA Has Approved A Label Update For Leqvio Allowing Its Use As Monotherapy Along With Diet And Exercise To Reduce Low-Density Lipoprotein Cholesterol In Adults With Hypercholesterolemia1.

• Leqvio can now be used alone, without addition of statin therapy, as adjunct to diet and exercise for LDL-C reduction in patients with hypercholesterolemia (high LDL-C)1
  
  
  
   
• 4 out of 5 atherosclerotic cardiovascular disease (ASCVD) patients do not reach guideline-recommended LDL-C target, reinforcing urgent need for more aggressive LDL-C lowering2-5
  
  
  
   
• Twice-yearly Leqvio is uniquely positioned to help support patient adherence and long-term LDL-C management, including goal attainment

Novartis announced today 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 hypercholesterolemia1. The FDA proactively requested the label update based on the robust LDL-C lowering data for PCSK9-targeting therapies.

"This first-line label update reinforces Leqvio's proven ability to effectively lower LDL-C, a critical risk factor for heart disease," said Victor Bultó, President, US, Novartis. "With this new indication enabling Leqvio's use as monotherapy along with diet and exercise, we now have the potential to help even more patients achieve their LDL-C lowering goals earlier in their treatment journey."

With its twice-yearly, health care provider-administered dosing, Leqvio is uniquely positioned to help support patient adherence and long-term LDL-C management, including goal attainment. This is a critical unmet need, as up to 80% of ASCVD patients in the US struggle to reach the LDL-C guideline-recommended target of <70 mg/dL2-5. This need is heightened by the latest 2025 ACC/AHA Joint Committee Clinical Practice Guideline for the Management of Patients with Acute Coronary Syndromes, which recommends more aggressive treatment to achieve LDL-C targets6.

The updated label removes the requirement for Leqvio to be used on top of or in combination with statin therapy1. Other updates include revising "primary hyperlipidemia" to the more specific term of "hypercholesterolemia" throughout the label, to more accurately focus on LDL-C reduction1.