Novartis' Leqvio Receives FDA Approval for New Indication in LDL Cholesterol Reduction

Novartis' Leqvio has received FDA approval for a new indication, allowing it to be used alone to lower LDL cholesterol in adults through diet and exercise. The approval updates the drug's label and expands its use beyond previous indications. Leqvio is a cholesterol-lowering drug that has been shown to be effective in reducing LDL levels. The approval is a significant development for Novartis and could potentially increase the drug's market share in the cardiovascular disease treatment market.

Novartis (NYSE: NVS) has received a significant boost with the FDA's approval of a label update for Leqvio® (inclisiran), enabling its use as a first-line monotherapy for LDL-C reduction in adults with hypercholesterolemia. The update removes the requirement for combination with statin therapy, allowing Leqvio to be used alone with diet and exercise [1].

The FDA's proactive request for this label update was based on robust LDL-C lowering data for PCSK9-targeting therapies. This development is particularly significant as up to 80% of ASCVD patients in the US struggle to reach the LDL-C guideline-recommended target of 70 mg/dL [2]. Leqvio's unique twice-yearly dosing regimen, administered by healthcare providers, aims to support better patient adherence and long-term cholesterol management.

The approval significantly expands Novartis's addressable market in high-cholesterol patients, boosting commercial potential. The timing aligns perfectly with the 2025 ACC/AHA guidelines recommending more aggressive LDL-C targets, highlighting substantial unmet need that Leqvio can now address earlier in the treatment journey [3].

Leqvio's twice-yearly administration schedule gives it a compelling adherence advantage over daily oral medications or even monthly/bi-monthly injectable PCSK9 inhibitors. This approval strengthens Novartis's cardiovascular portfolio at a time when many pharmaceutical companies face patent cliffs and pricing pressures in established therapeutic areas.

References:
[1] https://www.stocktitan.net/news/NVS/novartis-twice-yearly-leqvio-inclisiran-receives-fda-approval-for-uf8lhrtjy04r.html
[2] https://www.marketscreener.com/news/novartis-twice-yearly-leqvio-inclisiran-receives-fda-approval-for-new-indication-enabling-first-ce7c5fddd081f725