Novartis Secures Approval for Expanded Paediatric Chronic Heart Failure Indication for Entrust® Tablet, an Angiotensin Receptor Neprilysin Inhibitor (ARNI)

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Novartis Pharma K.K. (Novartis Pharma) has received approval for an expanded treatment indication of pediatric chronic heart failure for Entresto® Tablets, an angiotensin receptor neprilysin inhibitor (ARNI) available in 50 mg, 100 mg, and 200 mg dosages (generic name: sacubitril valsartan sodium hydrate, referred to as Entresto hereafter). This approval marks the first in Japan for dosage and administration specific to chronic heart failure in pediatric patients.

In Japan, dissemination of information regarding Entresto to healthcare professionals will be jointly conducted by Novartis Pharma and Otsuka pursuant to a co-promotion agreement.

Product Information: Entresto® Tablets 50 mg (Entresto® Tablets) Entresto® Tablets 100 mg Entresto® Tablets 200 mg

Nonproprietary Name: Sacubitril Valsartan Sodium Hydrate

Indications* (Underlined items indicate additions): Entresto Tablets 50 mg, 100 mg, 200 mg Adults Chronic heart failure Use is restricted to patients already receiving standard treatment for chronic heart failure. Children Chronic heart failure

Entresto Tablets 100 mg, 200 mg Hypertension

Dosage and Administration* (Underlined items denote additions): Chronic heart failure The typical starting dose for adults is 50 mg of sacubitril valsartan administered orally twice daily. If tolerated, the dosage should be gradually increased to 200 mg over 2 to 4 weeks. A single dose is 50 mg, 100 mg, or 200 mg, taken orally twice daily. Dosage adjustments should be made according to the patient’s tolerance. For children aged ≥ 1 year, the starting dose of sacubitril valsartan is administered orally twice daily based on body weight, as indicated in the table below. Similar to adults, dosage adjustments should be made gradually over 2 to 4 weeks, with reductions according to patient tolerability.

Hypertension The usual adult dosage is 200 mg of sacubitril valsartan administered orally once daily. Dosage adjustments may be made based on age and symptoms, with a maximum daily dose of 400 mg.

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