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October 02, 2019
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FDA approves sacubitril/valsartan for pediatric HF

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Novartis announced that sacubitril/valsartan has been approved by the FDA for the treatment of children aged 1 year and older with symptomatic HF and systemic left ventricular systolic dysfunction.

Perspective from Jason F. Goldberg, MD

The drug (Entresto) reduces N-terminal pro-B-type natriuretic peptide, which leads to improved CV outcomes, according to a press release from the company.

Pediatric heart failure is extremely serious and carries a substantial burden,” Andrea Baer, executive director at Mended Little Hearts, said in the release. “Given the significant unmet need for heart failure treatments that are proven safe and effective in pediatric patients, this approval and the availability of a new treatment option is great news for these children and their families.”

The approval was based on 12-week analysis of the PANORAMA-HF trial, which showed that sacubitril/valsartan reduced NT-proBNP in children with HF from systemic LV systolic dysfunction. Data from the PARADIGM-HF trial were also considered for this approval, which also showed improved outcomes and reduced NT-proBNP in adults.

“The current clinical management of pediatric systolic heart failure includes the use of several medicines based mostly on data from adult studies, and there is limited data in children with heart failure in clinical trials,” David Soergel, MD, global head of cardiovascular, renal and metabolic drug development for Novartis, said in the release. “PANORAMA-HF is ongoing to secure 52-week follow-up data for the full study population.”

Disclosure s : Baer is an employee of Mended Little Hearts. Soergel is an employee of Novartis.