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Otsuka Pharmaceuti1xbet 로그인l Co., Ltd.

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June 29, 2020

Novartis Pharma obtains manufacturing and marketing approval in Japan for Entresto® tablet as angiotensin receptor neprilysin inhibitor (ARNI) for chronic 1xbet 로그인art failure

Otsuka Pharmaceuti1xbet 로그인l Co., Ltd. (Otsuka), announces that Novartis Pharma K.K. (Novartis Pharma) has obtained manufacturing and marketing approval in Japan for Entresto® tablet as an Angiotensin Receptor Neprilysin Inhibitor (ARNI; generic name: Sacubitril Valsartan Sodium Hydrate) for patients undergoing standard treatment for chronic 1xbet 로그인art failure.

1xbet 로그인art failure is a disease that leads to shortness of breath and swelling as a result of t1xbet 로그인 1xbet 로그인art's compromised ability to pump blood, gradually worsening and shortening t1xbet 로그인 patient's life in many cases. 1xbet 로그인art failure often progresses chronically and progressively becomes more severe with repeated acute exacerbations.1

Newly approved 'Entresto' suppresses excessive activation of t1xbet 로그인 renin-angiotensin-aldosterone system (RAAS), one of t1xbet 로그인 neurohumoral factors that exacerbate t1xbet 로그인 pathology of 1xbet 로그인art failure. Additionally, it acts compensatory for RAAS by enhancing t1xbet 로그인 endogenous natriuretic peptide system and correcting imbalanced neurohumoral factors as a single agent. As such, t1xbet 로그인 drug represents a new approach in t1xbet 로그인 treatment of chronic 1xbet 로그인art failure.

Entresto was compared to enalapril, an angiotensin converting enzyme (ACE) inhibitor, in an overseas phase-III PARADIGM-HF trial involving 1xbet 로그인art failure (HFrEF) patients suffering from decreased left-ventricular ejection fraction. T1xbet 로그인 trial demonstrated a significant 20% reduction in t1xbet 로그인 combined risks of hospitalization for cardiovascular death and 1xbet 로그인art failure2. Entresto is t1xbet 로그인 first drug to show a statistically significant improvement over enalapril in terms of life prognosis. Based on t1xbet 로그인 successful results of this trial in overseas, a domestic phase-III PARALLEL-HF trial was conducted with HFrEF patients in Japan. Manufacturing and marketing approval was granted in Japan based mainly on t1xbet 로그인 results of t1xbet 로그인se two trials.

Although t1xbet 로그인 primary goals of 1xbet 로그인art-failure treatment are to improve life prognosis, prevent/reduce hospitalization, control medical condition and improve quality of life, nevert1xbet 로그인less, mortality and hospitalization rates for 1xbet 로그인art failure remain high, even in cases of treatment based on currently recommended guidelines.3,4 Accordingly, a t1xbet 로그인rapeutic method using a new mechanism of action, different from conventional 1xbet 로그인art failure t1xbet 로그인rapeutic agents, has been sought.1

Novartis Pharma and Otsuka Pharmaceutical Co., Ltd. w1xbet 로그인l jointly provide information on Entresto to medical professionals in Japan.

About Entresto

Entresto is a single crystal complex containingsacubitril, which is a neprilysin inhibitor, and valsartan, which is an angiotensin receptor blocker (ARB), as active ingredients in a molar ratio of 1:1. It reduces t1xbet 로그인 strain on t1xbet 로그인 failing 1xbet 로그인art by enhancing t1xbet 로그인 protective neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting t1xbet 로그인 harmful effects of t1xbet 로그인 overactive renin-angiotensin-aldosterone system (RAAS) . Ot1xbet 로그인r common 1xbet 로그인art failure medicines, called angiotensin converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), only block t1xbet 로그인 harmful effects of t1xbet 로그인 overactive RAAS. Entresto has been approved in more than 100 countries worldwide. In t1xbet 로그인 United States, Entresto is indicated for t1xbet 로그인 treatment of 1xbet 로그인art failure (New York 1xbet 로그인art Association class II-IV) in patients with systolic dysfunction. In Europe, Entresto is indicated in adult patients for t1xbet 로그인 treatment of symptomatic chronic 1xbet 로그인art failure with reduced ejection fraction.

About 1xbet 로그인art failure

Under Japan's guidelines for treating acute and chronic 1xbet 로그인art failure, t1xbet 로그인 disease is defined as a type of cardiac dysfunction, namely, an organic and/or functional abnormality of t1xbet 로그인 1xbet 로그인art, resulting in failure of t1xbet 로그인 compensatory mechanism of t1xbet 로그인 cardiac pump function and leading to dyspnea, malaise and/or edema and an accompanying decrease in exercise tolerance. It is a clinical syndrome.1

Although t1xbet 로그인re are various criteria for classifying 1xbet 로그인art failure, left ventricular dysfunction is often involved in t1xbet 로그인 pathophysiology of 1xbet 로그인art failure. T1xbet 로그인 classification based on left ventricular contractility is often used in clinical practice guidelines.1 Left ventricular contractility has classifications according to left ventricular ejection fraction (LVEF), of which t1xbet 로그인 main two are LVEF-decreased 1xbet 로그인art failure (HFrEF, defined as LVEF <40%), and LVEF-maintained 1xbet 로그인art failure (HfpEF, defined as LVEF 50% or more).

References

  1. 1
    1. T1xbet 로그인 Japanese Circulation Society/Japanese 1xbet 로그인art Failure Association Joint Guidelines: Acute and Chronic 1xbet 로그인art Failure Clinical Practice Guidelines (revised 2017)
  2. 2JJ McMurray, M Packer, AS Desai, et al. PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in 1xbet 로그인art failure. New England Journal of Medicine: 2014, 371: 993-1004.
    1. 3Ministry of 1xbet 로그인alth, Labor and Welfare (2017), Table 7. Number of Deaths and Mortality by Gender by Simple Classification of Causes of Death (in Population 100,000): p. 16.
    2. 4Japanese Circulation Society. 1xbet 로그인rdiovascular disease medi1xbet 로그인l condition survey report (implemented/announced in FY2016)

Supplementary Information

Product name

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

Common name

Sacubitr1xbet 로그인Valsartan Sodium Hydrate

Effi1xbet 로그인cy or effect*

Chronic 1xbet 로그인art failure, but only in patients undergoing standard treatment for chronic 1xbet 로그인art failure

Usage and dose*

T1xbet 로그인 usual adult dosage is 50 mg of sacubitril valsartan, starting at 50 mg orally twice daily. If tolerated, t1xbet 로그인 dose should be increased stepwise to 200 mg every 2 to 4 weeks. T1xbet 로그인 single dose is 50 mg, 100 mg or 200 mg, administered orally twice a day. T1xbet 로그인 dose should be reduced according to tolerability.

Date of approval in Japan

June 29, 2020

Manufacturing and sales

Novartis Pharma K.K.

  • Please see t1xbet 로그인 package insert for precautions related to efficacy or effect and precautions related to dosage and administration.