Pharma Focus Asia

Novartis Announces Positive CHMP Opinion for Entresto

Saturday, April 01, 2023

Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of Entresto (sacubitril/valsartan) for a new indication to treat symptomatic chronic heart failure with left ventricular systolic dysfunction in paediatric patients aged from 1 to <18 years.

This positive opinion paves the way for Novartis to provide effective age-appropriate treatment for children with heart failure diagnosed with left ventricular systolic dysfunction and their families in the EU, helping to address a large unmet need.

In this new indication the CHMP concluded that Entresto brings an important contribution to patient care and therefore fulfils the criteria of significant clinical benefit. If approved, Entresto will become available to children with a new age-appropriate formulation to enable accurate and convenient administration for these patients and their caregivers. This will support extension of the regulatory data protection to November 2026.

Entresto has been approved in the EU since 2015 in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF). In the US, Entresto is indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in adult patients with chronic heart failure, and has been approved since October 2019 to treat childhood heart failure due to left ventricular systolic dysfunction.

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