The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein cholesterol management.
The FDA has approved a label update for Novartis' Leqvio (inclisiran), allowing it to be used as a first-line monotherapy alongside diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. According to the company, the FDA initiated the label update in response to strong LDL-C lowering evidence supporting PCSK9-targeting therapies.1
"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, in a press release. "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."
Historically indicated for use in combination with statins, Novartis said the updated label broadens Leqvio’s utility and reflects strong clinical data supporting PCSK9-targeting therapies. Additionally, the label now uses the more precise term "hypercholesterolemia" in place of "primary hyperlipidemia" to better reflect its focus on LDL-C reduction.
The company also noted that the label update meets an unmet need, with up to 80% of patients with atherosclerotic cardiovascular disease (ASCVD) facing challenges in achieving the LDL-C guideline-recommended target of less than 70 mg/dL.1
Leqvio was first approved by the FDA on December 22, 2021, as the first and only small interfering RNA to reduce LDL-C with two doses a year, after an initial dose and one at three months.2
This latest FDA label update for Leqvio isn’t its first expansion, as it's part of an ongoing effort to expand the therapy’s use and reinforce its role in LDL-C management. On July 10, 2023, the FDA approved a label update for the drug to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy. Additional label changes included eliminating the Limitations of Use statement and streamlining the safety section by removing four adverse events (AEs), as their occurrence rates matched those seen in the placebo group.3
Common AEs reported in clinical trials for Leqvio included injection site reaction, arthralgia, and bronchitis. Novartis warns that Leqvio is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in Leqvio. Additionally, Leqvio should be discontinued during pregnancy due to potential fetal harm based on its mechanism of action, and because lipid-lowering treatment is generally not necessary during this time.4
According to Novartis, ASCVD accounts for approximately 85% of all cardiovascular deaths, with a burden higher than any other chronic disease in the United States. Cardiovascular disease (CVD) leads to more deaths than cancer, chronic lung disease, and diabetes combined. However, an estimated 80% of premature cardiovascular deaths could be avoided by targeting the underlying causes and risk factors of CVD.1
Novartis initially acquired the rights to develop, manufacture, and commercialize Leqvio through a licensing and collaboration agreement with Alnylam Pharmaceuticals.2
"Novartis is committed to addressing the rising burden of cardiovascular disease, a substantial public health burden affecting 30 million Americans," said Bulto, in a July 2023 press release. "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."3
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