Entresto, the novel combination therapy which combines Sacubitril and Valsartan, was FDA approved on July 7, 2015. Previously known as the investigational compound LCZ696, Entresto received an FDA nod to reduce the risk of both hospitalization and cardiovascular mortality in patients with chronic heart failure, especially those with a reduced ejection fraction and an NYHA Class II-IV diagnosis.
Perhaps the biggest news-maker from this FDA nod is the novel molecule Sacubitril, getting it’s first FDA approval. Sacubitril is an effectual first-in-class neprilysin inhibitor. Combined with the angiotensin receptor antagonist Valsartan, Entresto shined in comprehensive studies.
The FDA decided to quickly approve Entresto, which is marketed by Novartis, after receiving results from a vast study coined PARADIGM-HF. This study has proven to be the largest clinical trial ever conducted in patients with heart failure to date. The FDA’s decision is based on results from the 8,442-patient who were enrolled in this trial, which proved Entresto was both clinically and statistically superior to Enalapril, a standard ACE inhibitor used for heart failure therapy. Entresto drove the risk of cardiac mortality and hospitalization from heart failure down by 20 percent in the trial, meeting the primary study endpoint. Adverse effects from Entresto were not deemed severe, and included dizziness, cough, and lowered blood pressure, as well as higher than normal potassium levels, which could affect patients with preexisting kidney disease.
A staggering six million people in the United States are suffering from heart failure, with nearly half of these patients also exhibiting the reduced ejection fraction form of this disease. Patients diagnosed with chronic heart failure endure repeated hospital visits, fluid retention, breathlessness, extreme fatigue and face a high risk of mortality. The ageing population both in the U.S. and worldwide will undoubtedly lead to more cases of heart failure being diagnosed, and experts predict a hefty eight million Americans will be diagnosed with heart failure by 2030.
Entresto has been approved in three dosage strengths: 24/26 milligrams, 49/51 milligrams, and 97/103 milligrams of Sacubitril/Valsartan, respectively. The NEJM has referred to these dosages as 50 milligrams, 100 milligrams, and 200 milligrams for clinical trial literature purposes regarding the PARADIGM-HF results. The optimal dose for patients with heart failure who have a reduced ejection fraction and are classified as having a NYHA Class II-IV diagnosis is 97/103 milligrams of Entresto twice a day by mouth.
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