Novartis drug could be breakthrough in heart failure

A new treatment, LCZ696, has produced exceptionally impressive results in cutting risk of death in heart failure patients, and has been heralded as a major breakthrough in the condition.

The potential of the drug, developed by Novartis, became clear in March when its phase III trial was stopped early, but full data unveiled at the European Society of Cardiology meeting in Barcelona at the weekend showed it could potentially revolutionise treatment.

The drug showed exceptional results in heart failure patients with reduced ejection fraction (HF-REF): reducing the risk of death from cardiovascular causes by 20 per cent; reducing heart failure hospitalisations by 21 per cent; and reduced the risk of all-cause mortality by 16 per cent.

Overall, LCZ696 produced a 20% risk reduction on the primary endpoint, a composite measure of CV death or heart failure hospitalisation.

These results have been acclaimed as a major step forward in treating the disease, and means that Novartis has a blockbuster drug on its hands. There is no consensus yet among analyst on how much the drug could generate in peak sales, but Bernstein's Tim Anderson forecasts that LCZ696 could reach as high as $8 billion.

"By demonstrating a very significant reduction in cardiovascular deaths while improving quality of life, Novartis' new heart failure medicine, LCZ696, represents one of the most important cardiology advances of the last decade," said David Epstein, division head, Novartis Pharmaceuticals.

"We want to thank leading cardiologists from around the world for their collaboration with us and their determination in advancing this important new life saving therapy for heart failure patients."

LCZ696 is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart. It acts to enhance the protective neurohormonal systems of the heart (NP system) while simultaneously suppressing the harmful system (the RAAS).

Currently available medicines for HF-REF work only to block the detrimental effects. Despite existing therapies, the mortality rate remains very high with up to 50% of patients dying within five years of a diagnosis of heart failure. Approximately half of patients with heart failure have HF-REF.

Novartis plans to file the drug with the FDA by the end of 2014 and in the EU in early 2015. A further advantage for Novartis is that the drug has no immediate rivals, giving it a clear run at developing the market.

Novartis has another heart failure drug in its late-stage pipeline, serelaxin (RLX030), which had looked like the more promising of the two candidates, but was rejected by an FDA committee in March because of doubts about its clinical evidence base.