Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Novartis Pharma K.K. (Novartis Pharma) has obtained approval for the additional treatment indication of pediatric chronic heart failure for an angiotensin receptor neprilysin inhibitor (ARNI), Entresto_® Tablets 50 mg, 100 mg, and 200 mg (generic name: sacubitril valsartan sodium hydrate, hereinafter Entresto). This drug is the first in Japan to receive dosage and administration approval for the indication of chronic heart failure in pediatric patients.

In Japan, activities to provide information on Entresto to healthcare professionals will be conducted by Novartis Pharma and Otsuka based on a co-promotion agreement.

Product name:
Entresto_® Tablets 50 mg (Entresto_® Tablets)
Entresto_® Tablets 100 mg
Entresto_® Tablets 200 mg

Nonproprietary name:
Sacubitril Valsartan Sodium Hydrate

Indications* (underline denotes additions):
Entresto Tablets 50 mg, 100 mg, 200 mg
Adults
Chronic heart failure
Use only in patients receiving standard treatment for chronic heart failure.
Children
Chronic heart failure

Entresto Tablets 100 mg, 200 mg
Hypertension

Dosage and Administration* (Underlines denote additions.):
Chronic heart failure
The usual adult starting dose is 50 mg of sacubitril valsartan administered orally twice daily. If tolerated, dosage should be increased stepwise to 200 mg at the intervals of 2 to 4 weeks. A single dose is 50 mg, 100 mg, or 200 mg, and either dose is orally administered twice daily. The dosage should be reduced according to patient's tolerability.
The usual starting dose of sacubitril valsartan for children aged ≥ 1 year is administered orally twice daily according to body weight as shown in the table below. If tolerated, dosage should be increased stepwise at 2~4 week intervals. The dosage should be reduced according to patient's tolerability.

Hypertension
The usual adult dosage is 200 mg of sacubitril valsartan administered orally once daily. The dose may be adjusted according to the patient's age and symptoms. The maximum dose is 400 mg once daily.

Recipient of Marketing Authorization:
Novartis Pharma K.K.