September 27, 2021
Otsuka Pharmaceutical Co., Ltd.
Otsuka announces that Novartis Pharma's ENTRESTO® received a new indication for treatment of hypertension in Japan
Otsuka collaborating with Novartis to provide information on ENTRESTO to medical professionals in Japan
Otsuka Pharmaceutical Co., Ltd. (Otsuka), announces that Novartis Pharma K.K. (Novartis Pharma) has obtained approval in Japan for ENTRESTO® 100 mg and 200 mg Tablets (generic name: sacubitril valsartan sodium hydrate) for the new indication of hypertension. This approval is Japan's first of an ARNI for the indication of hypertension.
ENTRESTO is classified as a new class called an angiotensin receptor neprilysin inhibitor (ARNI) with a novel mechanism of action that simultaneously inhibits neprilysin (NEP) and the renin-angiotensin-aldosterone system (RAAS).
The phase III pivotal trial for Japanese patients with mild or moderate essential hypertension assessed ENTRESTO in comparison to the angiotensin II receptor blocker (ARB) olmesartan. When administered at a dose of 200 mg once daily, ENTRESTO demonstrated a significant antihypertensive effect over olmesartan.*1 In addition, ENTRESTO showed an sustained blood-pressure-lowering effect of over 24 hours which was superior to olmesartan. Throughout clinical trials, the safety and tolerability of ENTRESTO have been shown to be comparable to existing ARBs.*2
ENTRESTO has been approved in more than 115 countries worldwide, including approval in Japan in June 2020 for the treatment of chronic heart failure (CHF).
Based on a co-promotion agreement, Novartis Pharma and Otsuka began to collaborate in offering information on ENTRESTO to healthcare providers in Japan following the initial approval for CHF in 2020 and the collaboration will now extend to the additional treatment indication of hypertension.
Hypertension is a chronic condition in which blood pressure levels remain above normal, with a high prevalence in the elderly. Persistent hypertension is known to increase the risk of morbidity and mortality from cerebrovascular disease and chronic kidney disease. It is therefore important that blood pressure is controlled to an appropriate level. Treatment of hypertension includes both pharmacological measures and non-pharmacological measures, including lifestyle modification, but in most cases, medicinal treatment using anti-hypertensive medicine is required to achieve anti-hypertensive targets.
In Japan, although several anti-hypertensive medicines with different mechanisms of action are available, less than 50 percent of patients taking anti-hypertensive medicine have a blood pressure of less than 140/90 mmHg.*3 In recent years, it has been suggested that blood pressure measured over a 24-hour period is highly prognostic for the development of cerebrovascular disease, while existing anti-hypertensive medicines have been shown to be difficult to maintain an adequate anti-hypertensive effect over a 24-hour period in clinical practice.*3
- Development files for ENTRESTO tablets 100 mg and 200 mg
- Novartis data on file. Japanese Ph 3 study
- Hypertension treatment guideline 2019 (JSH2019)
Information in this news release was current as of the original release date.