First-in-Class Heart Failure Drug Receives FDA Approval

The FDA today approved sacubitril/valsartan (Entresto) for treating heart failure.

The treatment is expected to decrease hospital admissions and extend the life for patients with heart failure with reduced ejection fraction.

Entresto was tested in a trial of more than 8000 patients and was shown to reduce the rate of cardiovascular death and hospitalization related to heart failure when compared with enalapril. Many patients involved in the trial were also taking approved heart failure treatments, such as beta-blockers, diuretics, and mineralocorticoid antagonists.

According to drug manufacturer Novartis, Entresto was able to reduce the risk of death from cardiovascular causes by 20%, reduce heart failure hospitalizations by 21%, and reduce the risk of all-cause mortality by 16%.

Common side effects may include hypotension, hyperkalemia, and renal impairment. Patients may also experience angioedema, especially among African-American patients and those with a prior history of angioedema.

Pharmacists and other health care professionals should make sure patients taking Entresto should not be on any drug from the angiotensin converting enzyme (ACE) inhibitor class, because they may be at greater risk of angioedema. According to the FDA, use of an ACE inhibitor and Entresto should be separated by 36 hours.

Entresto should also not be taken by pregnant women, as the treatment may pose a risk to an unborn baby.

Novartis recently announced it would not use a pay-per-pill method for Entresto; instead, it will use a clinical outcomes-based pricing model. Patients will get a discount for the drug when they purchase it, but they may have to pay more later if Entresto proves to reduce hospital admissions and associated costs. Sales are expected to be strong for the heart failure medicine.

The drug is “beyond what [clinicians have] been able to do previously with therapies that we have currently,” Tom Frank, PharmD, BCPS, told Pharmacy Times in an exclusive interview.

The FDA had granted priority review to Novartis’ investigational drug, which had previously been called LCZ696. It was designed to boost the heart’s protective neurohormonal systems and suppress its more harmful systems, thereby alleviating the strain on the heart, according to the manufacturer.

“Heart failure is a leading cause of death and disability in adults,” Norman Stockbridge, MD, PhD, director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “Treatment can help people with heart failure live longer and enjoy more active lives.”