Otsuka Pharmaceutical Co., Ltd.

March 26, 2024

Novartis receives approval in Japan for Entresto® Granular Tablets for Pediatric Use,
a formulation dedicated for pediatric patients with chronic heart failure

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that Novartis Pharma K.K. (Novartis Pharma) has received approval for Entresto® Granular Tablets for Pediatric Use 12.5 mg / 31.25 mg (generic name: sacubitril valsartan sodium hydrate, hereinafter referred to as Entresto Granular Tablets), an angiotensin receptor neprilysin inhibitor (ARNI).

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.

About Entresto
Entresto is classified as an angiotensin receptor neprilysin inhibitor (ARNI) with a mechanism of action that simultaneously inhibits neprilysin (NEP) and the renin-angiotensin-aldosterone system (RAAS).

In Japan, Entresto Tablets was approved for the indication of chronic heart failure and hypertension in June 2020 and September 2021, respectively. The indication, dosage and administration of Entresto Tablets for the treatment of chronic heart failure in pediatric patients were approved in February 2024.

Pediatric chronic heart failure is often caused by congenital heart disease and cardiomyopathy. Patients may not only experience symptoms such as difficulty breathing, but also develop aggravated cardiac hypertrophy and cardiomegaly with the disease progression, which may result in arrhythmia and sudden death. Therefore, early diagnosis and appropriate treatment are essential.1,2,3


1. Mitsunori Nishiyama, "Diagnosis and Initial Treatment of Pediatric Heart Failure," Pediatric Clinical Practice 2012; 65(7):1621-6.
2. Sharma M, Nair M, Jatana SK, et al. "Congestive Heart Failure in Infants and Children." Med J Armed Forces India; 59(3): 2003, 228-33.
3. Andrews RE, Fenton MJ, Ridout DA, et al. "New-onset heart failure due to heart muscle disease in childhood: a prospective study in the United Kingdom and Ireland." Circulation; 2008, 117(1):79-84.