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FDA approves new heart failure combination therapy

The Food and Drug Administration (headquarters pictured) has approved a new drug for heart failure that has “overwhelming benefit” for patients, according to the researchers who trialled the medicine

Source: Wikimedia Commons

The US Food and Drug Administration reviewed Entresto under its priority review programme

The US Food and Drug Administration (FDA) has approved a new drug for heart failure that has “overwhelming benefit” for patients, according to the researchers who trialled the medicine.

Entresto is a combination of the angiotensin receptor blocker valsartan and the novel neprilysin inhibitor sacubitril. In a clinical trial of more than 8,000 patients (called PARADIGM-HF and published in The New England Journal of Medicine[1] in 2014) the drug combination was more effective than the current gold standard treatment. The results indicated that Entresto reduces deaths and hospital admissions by 20% compared with the angiotensin converting enzyme inhibitor enalapril and the trial was stopped seven months early. However, the new combination increases the risk of angioedema.

The FDA reviewed the medicine under its priority review programme and also granted the medicine fast-track designation, processes reserved for drugs that treat a serious illness and either provide a significant benefit over current medication or meet an unmet medical need, respectively.

In Europe, the medicine is currently being assessed for a licence by the European Medicines Agency.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20068932

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  • The Food and Drug Administration (headquarters pictured) has approved a new drug for heart failure that has “overwhelming benefit” for patients, according to the researchers who trialled the medicine

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