Entresto: A New Drug to Treat Heart Failure Approved by FDA
Abstract: Swiss pharmaceutical company Novartis' new heart failure drug Entresto has been approved by FDA, recently. It has become the first new drug to treat heart failure in the past decade.
Novartis' new heart failure drug Entresto, also known as LCZ696, was approved by the U.S. Food and Drug Administration on July 7, 2015. About 5.1 million people in the U.S. are affected by heart failure. For those heart failure patients, their hearts are not able to pump blood efficiently， which is usually caused by heart attacks and high blood pressure. Entresto has been reported to successfully reduce the cardiovascular death and hospitalization rate due to heart failure and it's the first new drug to treat heart failure that has been awaited for decades.
Entresto was approved under the FDA's priority review which is in particular for therapies that meet needs for patients suffered from life-threatening diseases. Different from the standard review process, priority review expedites the process from 10 months to 6 months. The priority review would be able to provide significant improvements in the treatment.
Entresto is a valsartan and sacubitril combination drug, which is the first drug classified as angiotensin-receptor-neprilysin inhibitors (ARNIs). Clinical trial namely PARADIGM-HF involving 8,442 adult patients was conducted to compare Entresto to the current standard drug enalapril, an angiotensin converting enzyme (ACE) inhibitor. Entresto has been shown to be the first prescription drug that demonstrates a lower 17% death rate compared to 19.8% of enalapril.
Novartis expects to price Entresto $12.50/day with a $5 billion market. Novartis is planning to add value beyond-the-pill and guarantee the medication adherence via remote health monitoring programs.