According to cardiologists, the drug has the potential to improve the lives of individuals who have the condition.
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Entresto will now be available on prescription in the United States for heart failure with reduced ejection fraction in patients whose condition is classified NYHA class II-IV, indicated to cut the risk of cardiovascular death and heart failure hospitalisation. This has been considered as an unusual move by the company.
According to statistics, more than five million Americans, and an estimated 26 million people worldwide, suffer from heart failure, in which the heart can not pump blood adequately to the body’s organs, often as a result of a heart attack or high blood pressure.
Entresto was named LCZ696 during its development, and scientists believe it could replace what are known as angiotensin-converting enzym (ACE) inhibitors, which are now used in the treatment of heart failure.
The drug will be priced at $12.50 a day at the wholesale level, which Novartis said was in line with other new cardiovascular treatments.
Mr. Epstein said the price was “really quite reasonable”, given that some drugs for other diseases cost many times that amount and confer less benefit.
“The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers”, said Dr. Milton Packer, Professor and Chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center, Texas, USA.
Novartis plans to begin shipping Entresto to the U.S.in the coming week, according to the statement. When switching between Entresto and an ACE inhibitor, use of the two drugs should be separated by 36 hours. That’s a difference of 20 percent. “As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital”, said David Epstein, Division Head of Novartis Pharmaceuticals. The agency approved another heart failure from Amgen Inc.in April.
A more serious adverse effect was angioedema, an allergic reaction characterized by swelling of the lips or face. Blacks and those with a previous history of the condition were at increased risk, it said.
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Research published past year in the New England Journal of Medicine found Entresto reduced the risk of death and hospitalization from heart failure by 20 percent compared with the standard therapy, enalapril. If that is the case, it would help Novartis as it will soon received generic competitions for Gleevec its cancer drug.
