Shares of manufacturer Novartis blasted off Tuesday with worth that the government had approved Entresto as a way to reduce death and hospitalizations from heart failure.
The Food and Drug Administration has officially approved a new weapon in the fight against heart failure: Entresto, which researchers believe can cut deaths from the condition by 20 percent.
Shares of manufacturer Novartis went through the roof on the news, as Entresto could reach more than $5 billion in annual sales thanks to the approval, making it one of the best-selling medications in the world, according to a New York Times report.
The medical community has been eagerly anticipating the drug ever since a large clinical trial posted a nearly 20 percent reduction in the risk of death from cardiovascular diseases or hospitalization from heart failure.
An official at Novartis called it a “once-in-a-decade” breakthrough. More than five million Americans — 26 million worldwide — suffer from heart failure when the heart cannot pump enough blood for the organs of the body, resulting in either high blood pressure or a heart attack. Shortness of breath, fatigue, and retention of fluids are typically the symptoms that lead to hospitalization.
Entresto, named LCZ696 during development, could replace angiotensin-converting enzyme (ACE) inhibitors which are currently being used for chronic heart failure. It would cost about $12.50 per day, or $4,500 per year. The patient would take two tablets each day.
In the clinical trial that was so successful, about 8,400 participants were randomly assigned to take either Entresto or an ACE inhibitor called enalapril. After 27 months, 21.8 percent of those who took Entresto had either died or been hospitalized due to heart failure, compared to 26.5 percent of those who took enalapril, a risk reduction of 20 percent.
About 2.2 million Americans would be eligible for the drug, Novartis believes.
The main side effects are low blood pressure, high potassium levels in the blood, and impairment of the kidney.
