New medicine to treat heart failure recommended for approval

EMA

25 September 2015 - The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Entresto (sacubitril with valsartan) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction, a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body. Around half of people with heart failure will have reduced ejection fraction.

Heart failure is a common and serious condition often caused by coronary artery disease (when the blood vessels supplying the heart become narrow), a heart attack or high blood pressure. Heart failure generally worsens over time. Although currently recommended treatments have improved the prognosis for people with heart failure, it remains alife-threatening disease which results in frequent hospital visits, and seriously impairs a patient’s ability to enjoy an active life.

Standard medicines used for patients with heart failure are angiotensin converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) if ACE inhibitors are not tolerated by the patient, in conjunction with beta-blockers and/or mineralocorticoid antagonists (MRAs). These medicines have been available for many years.

Entresto is a combination of valsartan (an ARB) and sacubitril. Sacubitril is the first in a new class of medicines called neprilysin inhibitors. Entresto works in two ways – valsartan blocks the angiotensin II type-1 receptor, suppressing the harmful effects of angiotensin II on the cardiovascular system while sacubitril blocks an enzyme known as neprilysin to enhance the protective neurohormonal systems of the heart. Because of its mechanism of action Entresto should not be given together with another ARB or with an ACE inhibitor.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/09/news_detail_002401.jsp&mid=WC0b01ac058004d5c1

Michael Wonder

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Michael Wonder