Novartis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion recommending approval of Entresto for a new indication to treat symptomatic chronic heart failure with left ventricular systolic dysfunction in pediatric patients aged from 1 to less than 18 years. David Soergel, M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis, said, "This positive opinion paves the way towards Novartis being able to provide children diagnosed with heart failure due to left ventricular systolic dysfunction in the EU and their families with an effective therapy in an age-appropriate formulation, helping to address what is a major unmet need."
Published first on TheFly
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