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Novartis' Leqvio Gains FDA Approval for First-Line Use

On July 31, 2025, Novartis Pharmaceuticals Corporation announced that its cholesterol-lowering medicine, Leqvio® (inclisiran), has received a significant label update from the US Food and Drug Administration (FDA). The updated approval allows Leqvio to be used as a standalone treatment—without the necessity for statin therapy—in conjunction with diet and exercise for patients suffering from hypercholesterolemia, a condition characterized by high levels of low-density lipoprotein cholesterol (LDL-C). This marks a pivotal moment in the management of high cholesterol levels, especially considering that approximately 80% of patients with atherosclerotic cardiovascular disease (ASCVD) fail to meet the recommended LDL-C targets outlined in clinical guidelines.

Victor Bultó, President of Novartis U.S., emphasized the importance of this approval, stating, "This first-line label update reinforces Leqvio's proven ability to effectively lower LDL-C, a critical risk factor for heart disease. 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."

Implications of the New Indication

The FDA's label update comes as a response to the growing need for effective LDL-C management tools in the face of cardiovascular diseases, which claim more lives globally than cancer, chronic lung disease, and diabetes combined. Given the rising challenges faced by ASCVD patients in achieving target LDL-C levels, Leqvio’s biannual administration by healthcare providers positions it uniquely for long-term management and adherence.

Clinical data have shown that nearly four out of five ASCVD patients do not reach the guideline-recommended LDL-C target of less than 70 mg/dL. This alarming statistic underscores the urgency for more aggressive LDL-C lowering strategies, a sentiment echoed in the recent 2025 ACC/AHA guidelines that recommend such treatments for acute coronary syndromes.

Enhancements to Leqvio’s Label

Furthermore, this label update also clarifies terminology: the term "hyperlipidemia" has been refined to specifically reference "hypercholesterolemia" to focus more directly on LDL-C reduction. This change in terminology speaks to the precision needed in addressing cholesterol-related health issues.

Leqvio, administered via injection, operates by silencing the PCSK9 gene responsible for cholesterol regulation, thereby leading to significant reductions in LDL-C levels. Alongside diet and exercise, this treatment not only serves as a viable option but also potentially boosts patient compliance, given its semi-annual dosing schedule.

Safety Information

While the approval for the standalone use of Leqvio is a significant advancement, it's imperative for patients and healthcare providers to discuss its safety profile. The most common side effects include injection site reactions, joint pain, and bronchitis. Patients are encouraged to consult healthcare providers for further medical advice and report any adverse effects.

Novartis’ Commitment to Cardiovascular Health

Novartis has long been dedicated to advancing cardiovascular health. Their mission focuses on ensuring that preventable cardiovascular deaths are significantly reduced. Over the last four decades, they have developed cutting-edge therapeutics and have collaborated with healthcare professionals to tackle the pressing challenges of heart disease head-on.

Through innovative treatments like Leqvio, Novartis aims to transform the landscape of cardiovascular care, enhancing the quality of life for patients burdened by these conditions and enabling them to enjoy longer, healthier lives.

In summary, the FDA's approval of Leqvio as a first-line treatment signifies a major milestone in the battle against high cholesterol and cardiovascular disease, paving the way for improved patient outcomes and expanding treatment options for healthcare providers.