2023-03-31 09:24:34 ET
- A committee of the European Medicines Agency (EMA) recommended expanding the approval of Novartis' ( NYSE: NVS ) Entresto to include children and adolescents with heart failure, and in two new strengths.
- The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Entresto for use in patients aged one year or older to treat symptomatic chronic heart failure with left ventricular systolic dysfunction.
- Entresto is already approved in the EU for use in adult patients for treating symptomatic chronic heart failure with reduced ejection fraction.
- The CHMP also adopted the addition of a new pharmaceutical form linked with two new strengths (Entresto 6 mg/6 mg and 15 mg/16 mg granules in capsule for opening).
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Novartis' heart drug Entresto gets EMA nod for expanded use in children