Novartis Reports Promising Leqvio Study Results, Demonstrates Strong Financial Health and Competitive Positioning

Novartis has reported encouraging Phase IV study results for Leqvio, showing significant improvements in LDL-C levels and reaching guideline-recommended targets in 85% of participants after 90 days. These positive outcomes were consistent across various demographics and contribute to the expanding evidence for Leqvio within the VictORION clinical initiative. Novartis boasts strong financial health, with a 13.1% revenue growth over the past year and a solid balance sheet. The company's diverse portfolio and commitment to innovation have enabled it to sustain growth and profitability, supported by prudent financial management.

Novartis has reported encouraging results from the Phase IV study, V-DIFFERENCE, which evaluated Leqvio (inclisiran) in combination with individually optimized lipid-lowering therapy (LLT) for patients with high cholesterol (hypercholesterolemia) who have not achieved guideline-recommended low-density lipoprotein cholesterol (LDL-C) goals. The study, presented at the 2025 European Society of Cardiology (ESC) Congress, demonstrated statistically significant and clinically meaningful early LDL-C goal achievement with reduced muscle pain.

After 90 days of treatment with Leqvio on top of LLT, 85% of patients achieved their guideline-recommended LDL-C target compared to 31% of those receiving placebo on top of LLT (p0.0001). Significant benefits were observed as early as 30 days, with 81% of patients achieving LDL-C targets. These results were consistent regardless of age, sex, or cardiovascular risk of trial participants. The study also showed that patients on Leqvio plus LLT were 43% less likely to experience muscle-related adverse events (MRAE) compared to those on placebo plus LLT (p0.0001).

Leqvio on top of LLT reduced LDL-C levels on average by 59% after 360 days of treatment, outperforming placebo plus LLT by 35% (p0.0001), with clinically significant differences observed as early as 60 days into treatment. These findings add to the growing body of evidence for Leqvio within the VictORION clinical program, which encompasses more than 60,000 patients from 50 countries worldwide.

Financial Perspective

Novartis' strong financial health is evident with a 13.1% revenue growth over the past year and a solid balance sheet. The company's diverse portfolio and commitment to innovation have enabled it to sustain growth and profitability, supported by prudent financial management. These positive study results for Leqvio could further bolster Novartis' financial performance by expanding its market reach and enhancing its product offerings in the cardiovascular disease space.

Conclusion

The encouraging results from the V-DIFFERENCE study highlight the potential of Leqvio to transform cardiovascular care by improving meaningful patient outcomes. With a robust financial foundation and a commitment to innovation, Novartis is well-positioned to capitalize on these advancements and continue its growth trajectory.

References
[1] https://www.globenewswire.com/news-release/2025/08/30/3141878/0/en/Novartis-Leqvio-shows-statistically-significant-and-clinically-meaningful-early-LDL-C-goal-achievement-with-less-muscle-pain.html