Information for patients about FDA cardiovascular-related product approvals, safety warnings, notices of upcoming public meetings, and notices about proposed regulatory guidances.
On July 7, 2015 the U.S. Food and Drug Administration approved Entresto (sacubitril/valsartan) tablets for the treatment of heart failure. The drug has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure.
Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can't pump enough blood to meet the body's needs. Heart failure generally worsens over time as the heart's pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as heart attacks and high blood pressure.
“Heart failure is a leading cause of death and disability in adults,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Treatment can help people with heart failure live longer and enjoy more active lives.”
Entresto was reviewed under the FDA’s priority review program, which provides for expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. It was also granted fast track designation, which supports FDA’s efforts to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need.
Entresto was studied in a clinical trial of more than 8,000 adults and was shown to reduce the rate of cardiovascular death and hospitalizations related to heart failure compared to another drug, enalapril. Most patients were also receiving currently approved heart failure treatments, including beta-blockers, diuretics, and mineralocorticoid antagonists.
The most common side effects in clinical trial participants being treated with Entresto were low blood pressure (hypotension), high blood potassium levels (hyperkalemia), and poor function of the kidneys (renal impairment).
Angioedema (an allergic reaction usually appearing as swelling of the lips or face) was also reported with Entresto; black patients and patients with a prior history of angioedema have a higher risk. Patients should be advised to get emergency medical help right away if they have symptoms of angioedema or trouble breathing while on Entresto. Health care professionals should advise patients not to use Entresto with any drug from the angiotensin converting enzyme (ACE) inhibitor class because the risk of angioedema is increased. When switching between Entresto and an ACE inhibitor, use of the two drugs should be separated by 36 hours.
Health care professionals should counsel patients about the risk of harm to an unborn baby. If pregnancy is detected, use of Entresto should be discontinued as soon as possible.
Entresto is manufactured by Novartis, based in East Hanover, New Jersey.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.