Novartis' Leqvio study shows promise in cholesterol treatment
Phase IV trial data reveals the drug helps patients achieve LDL-C goals with reduced muscle pain, bolstering its market position.
Novartis has unveiled promising results from a Phase IV study of its cholesterol-lowering drug, Leqvio, which could significantly enhance its profile in a competitive market. The V-DIFFERENCE trial, presented at the European Society of Cardiology Congress 2025, demonstrated that Leqvio, when added to standard lipid-lowering therapies, helped 85% of patients reach their LDL-C (low-density lipoprotein cholesterol) targets within 90 days, a substantial improvement over the 31% who achieved the same goals on placebo.
The study also highlighted a key benefit for patients: a 43% lower likelihood of experiencing muscle-related side effects, a common issue with statins. This dual benefit of efficacy and improved tolerability could make Leqvio a more attractive option for physicians and patients struggling to manage high cholesterol. "These findings are significant as they demonstrate effective options for lipid management improvement in patients at risk, a majority of whom continue to remain above recommended LDL-C levels," said Dr. Ulf Landmesser, Chairman of the Department of Cardiology at German Heart Center of Charité.
Leqvio, a twice-yearly injection administered by a healthcare provider, is a key growth driver for Novartis. Analysts project the drug's sales to reach $1.2 billion in 2025 and potentially as high as $3.4 billion by 2030. These latest clinical results are likely to reinforce those optimistic forecasts, especially as Novartis competes with established players like Amgen's Repatha and Sanofi and Regeneron's Praluent.
Novartis's stock (NVS) is trading near the top of its 52-week range, and while the consensus among Wall Street analysts is currently a 'Hold,' the positive data from the V-DIFFERENCE study could lead to revised ratings. The company has already raised its peak sales estimates for Leqvio, signaling its confidence in the drug's long-term potential.
"These results highlight the potential of Leqvio to transform cardiovascular care by improving meaningful patient outcomes," said Dr. Ruchira Glaser, Global Head of Cardiovascular, Renal and Metabolic Development at Novartis. The company's focus on patient-centered outcomes, such as reduced muscle pain, may help differentiate Leqvio in a crowded field and address some of the adherence challenges that have long plagued cholesterol management.