Combination of Sacubril and Valsartan for treatment of symptomatic chronic heart failure with reduced ejection fraction: CHMP has adopted a positive opinion
The Committee for Medicinal Products for Human Use ( CHMP ) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Entresto, intended for the treatment of symptomatic chronic heart failure with reduced ejection fraction.
Entresto will be available as 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg film-coated tablets. The active substances of Entresto are Sacubitril and Valsartan, and the medicine works in two complementary 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.
The benefit with Entresto is its ability to reduce the risk of cardiovascular death or need for heart failure hospitalisations as compared to Enalapril in patients with symptomatic chronic heart failure with reduced ejection fraction.
The most common side effects are hypotension, hyperkalaemia and renal impairment. Angioedema occurs uncommonly.
The full indication is: Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction. ( Xagena )
Source: EMA, 2015