Novartis announces clinical trial program for oral heart failure medication

Novartis announced a program that includes more than 40 clinical trials that will examine the safety, efficacy and real world outcomes of patients with heart failure who receive sacubitril/valsartan (Entresto).

In July 2015, the FDA approved sacubitril/valsartan, a twice-daily oral medication to treat patients with heart failure and reduced ejection fraction. Although the drug was expected to be a blockbuster, Novartis reported it had just $17 million in sacubitril/valsartan sales during the first quarter of 2016.

The company’s FortiHFy program will include patients from more than 50 countries and will last for five years. Novartis highlighted four trials that will be completed between 2018 and 2020 that will evaluate whether sacubitril/valsartan can be safe and effective and reduce adverse outcomes.

The FDA’s approval of sacubitril/valsartan was based on results of the PARADIGM-HF study, which found that sacubitril/valsartan significantly reduced the risk of cardiovascular mortality compared with enalapril.

Despite the slow sales so far, research and consulting firm GlobalData projects peak sales of sacubitril/valsartan could reach $5.1 billion in 2022.