The results of a study on a heart drug developed by Novartis of Switzerland that were presented in Barcelona on Saturday show that the medicine cut cardiovascular deaths by 20% when compared with a rival treatment, suggesting that the pharmaceutical group may have the prospect of a blockbuster with annual revenues of at least $1bn.
Novartis says that heart failure is the biggest single cause of hospital admissions in adults aged over 65 in the Western world. It affects 26m people worldwide and more than 1m new cases are diagnosed every year.
More people die from heart failure than from some advanced cancers, including breast and bowel cancer. Ageing populations and deteriorating lifestyles mean heart failure is the most rapidly growing cardiovascular condition. One in 5 people aged 40 and over will develop heart failure in their lifetime and the treatment costs are estimated at $65bn a year worldwide.
Despite this, it remains misunderstood. Rather than a sudden, total failure of the heart, it is a progressive weakening characterized by an inability of the heart to pump enough blood around the body. Treatments address symptoms such as fluid retention and breathlessness but there is no cure and survival rates have not improved over the past two decades.
Heart failure has many causes, from high blood pressure, coronary heart disease, kidney disease, diabetes, anemia to common viruses.
On Saturday at the European Society of Cardiology congress in Barcelona and published simultaneously in the New England Journal of Medicine, Novartis revealed that its investigational heart failure medicine, LCZ696, was superior to ACE-inhibitor enalapril on key endpoints in the largest heart failure study ever done, involving more than 8,400 patients. In PARADIGM-HF patients with heart failure with reduced ejection fraction who were given LCZ696 were more likely to be alive and less likely to have been hospitalised for sudden deterioration of their heart failure than those given ACE-inhibitor enalapril. Patients received LCZ696 or enalapril on top of current best treatment.
The magnitude of benefit with LCZ696 against enalapril in HF-REF patients was highly statistically significant and clinically important. In the study, the benefit of LCZ696 was seen early, was sustained and was consistent across subgroups. LCZ696:
- reduced the risk of death from cardiovascular (CV) causes by 20% (p=0.00004);
- reduced heart failure hospitalizations by 21% (p=0.00004);
- reduced the risk of all-cause mortality by 16% (p=0.0005)
Overall there was a 20% risk reduction on the primary endpoint, a composite measure of CV death or heart failure hospitalization (p=0.0000002).
"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."
The Wall Street Journal says that Novartis, Europe's second biggest drugs maker by market capitalization after Swiss rival Roche Holding Ltd., might earn between $2bn and $6bn in peak annual revenue from the drug, according to industry analysts.
The drug has side effects with patients receiving LCZ696 more likely than the enalapril group to experience hypotension, or low blood pressure, though the symptom caused very few patients to drop out of the program. Others experienced coughing, which is also a side effect of enalapril.