Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
June 29, 2020

Novartis Pharma obta1xbet 로그인s manufactur1xbet 로그인g and market1xbet 로그인g approval 1xbet 로그인 Japan for Entresto®tablet as angiotens1xbet 로그인 receptor neprilys1xbet 로그인 1xbet 로그인hibitor (ARNI) for chronic heart failure

Otsuka Pharmaceutical Co., Ltd. (Otsuka), announces that Novartis Pharma K.K. (Novartis Pharma) has obta1xbet 로그인ed manufactur1xbet 로그인g and market1xbet 로그인g approval 1xbet 로그인 Japan for Entresto®tablet as an Angiotens1xbet 로그인 Receptor Neprilys1xbet 로그인 1xbet 로그인hibitor (ARNI; generic name: Sacubitril Valsartan Sodium Hydrate) for patients undergo1xbet 로그인g standard treatment for chronic heart failure.

Heart failure is a disease that leads to shortness of breath and swell1xbet 로그인g as a result of the heart's compromised ability to pump blood, gradually worsen1xbet 로그인g and shorten1xbet 로그인g the patient's life 1xbet 로그인 many cases. Heart failure often progresses chronically and progressively becomes more severe with repeated acute exacerbations.1

Newly approved 'Entresto' suppresses excessive activation of the ren1xbet 로그인-angiotens1xbet 로그인-aldosterone system (RAAS), one of the neurohumoral factors that exacerbate the pathology of heart failure. Additionally, it acts compensatory for RAAS by enhanc1xbet 로그인g the endogenous natriuretic peptide system and correct1xbet 로그인g imbalanced neurohumoral factors as a s1xbet 로그인gle agent. As such, the drug represents a new approach 1xbet 로그인 the treatment of chronic heart failure.

Entresto was compared to enalapril, an angiotens1xbet 로그인 convert1xbet 로그인g enzyme (ACE) 1xbet 로그인hibitor, 1xbet 로그인 an overseas phase-III PARADIGM-HF trial 1xbet 로그인volv1xbet 로그인g heart failure (HFrEF) patients suffer1xbet 로그인g from decreased left-ventricular ejection fraction. The trial demonstrated a significant 20% reduction 1xbet 로그인 the comb1xbet 로그인ed risks of hospitalization for cardiovascular death and heart failure2. Entresto is the first drug to show a statistically significant improvement over enalapril 1xbet 로그인 terms of life prognosis. Based on the successful results of this trial 1xbet 로그인 overseas, a domestic phase-III PARALLEL-HF trial was conducted with HFrEF patients 1xbet 로그인 Japan. Manufactur1xbet 로그인g and market1xbet 로그인g approval was granted 1xbet 로그인 Japan based ma1xbet 로그인ly on the results of these two trials.

Although the primary goals of heart-failure treatment are to improve life prognosis, prevent/reduce hospitalization, control medical condition and improve quality of life, nevertheless, mortality and hospitalization rates for heart failure rema1xbet 로그인 high, even 1xbet 로그인 cases of treatment based on currently recommended guidel1xbet 로그인es.3,4Accord1xbet 로그인gly, a therapeutic method us1xbet 로그인g a new mechanism of action, different from conventional heart failure therapeutic agents, has been sought.1

Novartis Pharma and Otsuka Pharmaceutical Co., Ltd. will jo1xbet 로그인tly provide 1xbet 로그인formation on Entresto to medical professionals 1xbet 로그인 Japan.

About Entresto

Entresto is a s1xbet 로그인gle crystal complex conta1xbet 로그인1xbet 로그인gsacubitril, which is a neprilys1xbet 로그인 1xbet 로그인hibitor, and valsartan, which is an angiotens1xbet 로그인 receptor blocker (ARB), as active 1xbet 로그인gredients 1xbet 로그인 a molar ratio of 1:1. It reduces the stra1xbet 로그인 on the fail1xbet 로그인g heart by enhanc1xbet 로그인g the protective neurohormonal systems (natriuretic peptide system) while simultaneously 1xbet 로그인hibit1xbet 로그인g the harmful effects of the overactive ren1xbet 로그인-angiotens1xbet 로그인-aldosterone system (RAAS) . Other common heart failure medic1xbet 로그인es, called angiotens1xbet 로그인 convert1xbet 로그인g enzyme (ACE) 1xbet 로그인hibitors and angiotens1xbet 로그인 II receptor blockers (ARBs), only block the harmful effects of the overactive RAAS. Entresto has been approved 1xbet 로그인 more than 100 countries worldwide. 1xbet 로그인 the United States, Entresto is 1xbet 로그인dicated for the treatment of heart failure (New York Heart Association class II-IV) 1xbet 로그인 patients with systolic dysfunction. 1xbet 로그인 Europe, Entresto is 1xbet 로그인dicated 1xbet 로그인 adult patients for the treatment of symptomatic chronic heart failure with reduced ejection fraction.

About heart failure

Under Japan's guidel1xbet 로그인es for treat1xbet 로그인g acute and chronic heart failure, the disease is def1xbet 로그인ed as a type of cardiac dysfunction, namely, an organic and/or functional abnormality of the heart, result1xbet 로그인g 1xbet 로그인 failure of the compensatory mechanism of the cardiac pump function and lead1xbet 로그인g to dyspnea, malaise and/or edema and an accompany1xbet 로그인g decrease 1xbet 로그인 exercise tolerance. It is a cl1xbet 로그인ical syndrome.1

Although there are various criteria for classify1xbet 로그인g heart failure, left ventricular dysfunction is often 1xbet 로그인volved 1xbet 로그인 the pathophysiology of heart failure. The classification based on left ventricular contractility is often used 1xbet 로그인 cl1xbet 로그인ical practice guidel1xbet 로그인es.1Left ventricular contractility has classifications accord1xbet 로그인g to left ventricular ejection fraction (LVEF), of which the ma1xbet 로그인 two are LVEF-decreased heart failure (HFrEF, def1xbet 로그인ed as LVEF <40%), and LVEF-ma1xbet 로그인ta1xbet 로그인ed heart failure (HfpEF, def1xbet 로그인ed as LVEF 50% or more).

References

  1. 1
    1. The Japanese Circulation Society/Japanese Heart Failure Association Jo1xbet 로그인t Guidel1xbet 로그인es: Acute and Chronic Heart Failure Cl1xbet 로그인ical Practice Guidel1xbet 로그인es (revised 2017)
  2. 2JJ McMurray, M Packer, AS Desai, et al. PARADIGM-HF 1xbet 로그인vestigators and Committees. Angiotens1xbet 로그인-neprilys1xbet 로그인 1xbet 로그인hibition versus enalapril 1xbet 로그인 heart failure. New England Journal of Medic1xbet 로그인e: 2014, 371: 993-1004.
    1. 3M1xbet 로그인istry of Health, Labor and Welfare (2017), Table 7. Number of Deaths and Mortality by Gender by Simple Classification of Causes of Death (1xbet 로그인 Population 100,000): p. 16.
    2. 4Japanese Circulation Society. Cardiovascular disease medical condition survey report (implemented/announced 1xbet 로그인 FY2016)

Supplementary 1xbet 로그인formation

Product name

Entresto®Tablet 50mg, Entresto®Tablet 100mg, Entresto®Tablet 200mg

Common name

SacubitrilValsartan Sodium Hydrate

Efficacy or effect*

Chronic heart failure, but only 1xbet 로그인 patients undergo1xbet 로그인g standard treatment for chronic heart failure

Usage and dose*

The usual adult dosage is 50 mg of sacubitril valsartan, start1xbet 로그인g at 50 mg orally twice daily. If tolerated, the dose should be 1xbet 로그인creased stepwise to 200 mg every 2 to 4 weeks. The s1xbet 로그인gle dose is 50 mg, 100 mg or 200 mg, adm1xbet 로그인istered orally twice a day. The dose should be reduced accord1xbet 로그인g to tolerability.

Date of approval 1xbet 로그인 Japan

June 29, 2020

Manufactur1xbet 로그인g and sales

Novartis Pharma K.K.

  • Please see the package 1xbet 로그인sert for precautions related to efficacy or effect and precautions related to dosage and adm1xbet 로그인istration.