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    Home > Biochemistry News > Biotechnology News > Heavy! AstraZene Forxiga was approved in Japan

    Heavy! AstraZene Forxiga was approved in Japan

    • Last Update: 2020-12-11
    • Source: Internet
    • Author: User
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    Heart failure (HF) is a life-threatening chronic disease in which the heart is unable to deliver enough blood to the body, affecting about 64 million people worldwide, at least half of whom have lower blood test scores.
    occurs when the left chamber muscle does not contract sufficiently and less oxygenated blood is pumped into the body.
    forxiga is a daily oral oral option sodium glucose co-transport protein 2 (SGLT2) inhibitor.
    may, Farxiga received the world's first approval in the United States to treat adult patients with HFrEF.
    november, Forxiga was awarded in the European Union for the treatment of adult patients with HFREF.
    It is worth noting that Forxiga/Farxiga is the first SGLT2 inhibitor drug approved for the treatment of HFrEF and the first to be shown to significantly reduce the risk of cardiovascular (CV) death and heart failure in patients with HFrEF (with or without type 2 diabetes). prior to
    , the drug's approved symptoms included: (1) assisted diet and exercise to improve blood sugar control in people with type 2 diabetes, and (2) for patients with type 2 diabetes with CV disease or multiple CV risk factors, reducing the risk of hospitalization for heart failure.
    In the European Union and Japan, the drug is also approved for the treatment of type 1 diabetes, specifically as an oral-assisted treatment drug for insulin, which is used to improve blood sugar control in adult patients with type 1 diabetes (T1D) with poor blood sugar level control and body mass index (BMI) ≥27kg/m2 (overweight or obese) type 1 diabetes (T1D).
    this new adaptation approval, based on the results of the Milestone III DAPA-HF trial.
    data show that in adult patients with HFrEF (accompanied or not accompanied by type 2 diabetes), Forxiga/Farxiga improved survival and reduced the need for hospitalization when combined with standard care, significantly reducing the risk of CV death and heart failure (hospitalization for heart failure, emergency heart failure) compound endpoints by 26%.
    heart failure affects 1.3 million people in Japan," said Masafumi Kitakaze, a Japanese investigator on the Phase III DAPA-HF trial and a professor of medicine at Osaka University in Japan.
    heart function was significantly reduced in many patients, such as lower left ceria blood test scores.
    half of all patients die within five years of diagnosis, which is more serious than some cancers.
    there is no known cure other than a heart transplant, and based on current medical standards, a new and effective treatment could offer hope to people fighting the disease and provide a new tool for cardiologists.
    "Forxiga's effectiveness in reducing the risk of cardiovascular death or worsening heart failure events may bring life-saving benefits to many heart failure patients in Japan," said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZenece.
    today's approval will change the way we manage disease and provide a much-needed treatment to improve the prognostics and symptoms of these patients.
    " DAPA-HF is a joint standard care drug for evaluating SGLT2 inhibitors (including angiosin-converting enzyme (ACE) inhibitors, angiosin II blockers (ARB), β - The first study of heart failure outcomes in adult patients with HFrEF (with and without type 2 diabetes) was conducted with and without the treatment of saline corticosteroid antagonists (MRA) and cerebral morphinease inhibitors.
    This is an international, multi-center, parallel group, randomized, double-blind study conducted in heart failure patients (HFrEF) with reduced blood test scores (LVEF ≤40%) and included and without type 2 diabetes.
    study assessed the efficacy and safety of a daily 10 mg dose of Farxiga with a placebo, in a joint standard care treatment.
    end point of the study was the time of death from heart failure (hospitalization or equivalent events, such as emergency heart failure) or cardiovascular (CV) death.
    results show that the study reached the main compound endpoint: Farxiga significantly reduced the risk of cardiovascular (CV) death or worsening heart failure compound endpoints by 26% (p<0.0001) compared to placebo, and showed a compound endpoint The risk of each individual group was reduced by 30% (p<0.0001) and the risk of cardiovascular death by 18% (p-0.0294).
    effects of Farxiga on major composite endpoints were largely consistent among the key subgroups studied.
    addition, the results showed a significant improvement in patient reporting measured in the Kansas City Cardiomyopathy Questionnaire (KCCQ), with a significant 17 percent nominal reduction in all-cause mortality (7.9 vs. 9.5 per 100 patients per year), and the data favoring Farxiga.
    the study, Farxiga's safety was consistent with the safety determined by the drug.
    of patients with insufficient capacity (7.5% vs 6.8%) and kidney adverse events (6.5% vs 7.2%) were comparable to placebos, which is a common concern when treating heart failure.
    hypoglycemia events (0.2% vs. 0.2%) were rare in both treatment groups.
    heart failure (HF) is a life-threatening disease in which the heart does not pump enough blood into the body.
    heart failure affects about 64 million people worldwide, at least half of whom have reduced blood test scores, a chronic, debilitating disease in which half of patients die within five years of diagnosis.
    heart failure is still as fatal as the most common cancers in men (prostate and bladder) and women (breast cancer).
    heart failure is the main cause of hospitalization for patients over 65 years of age and represents a significant clinical and economic burden.
    Forxiga/Farxiga's active drug ingredient is dapagliflozin, a pioneering, daily oral, selective sodium-glucose co-transport protein (SGLT2) inhibitor that works independently of insulin and selectively inhibits SGLT2 in the kidneys to help patients excrete excess glucose from their urine.
    addition to lowering sugar, the drug has additional benefits for weight loss and lowering blood pressure.
    , Forxiga/Farxiga is also being evaluated for the treatment of chronic kidney disease (CKD), and phase III DAPA-CKD trials have been terminated early due to overwhelming efficacy data.
    addition, the drug is being evaluated for treatment of HF in the DELIVER (HFpEF) and DETERMINE (HFrEF and HFpEF) trials.
    the drug has a large clinical development program involving more than 35 completed or ongoing IIb/III clinical studies, more than 35,000 patients in the group, and more than 2.5 million years of clinical experience.
    china, Forxiga (Chinese brand name: Anda Tang) was approved in March 2017 as a single-drug therapy to improve blood sugar control in adults with type 2 diabetes.
    this approval, making dapagliflozin the first SGLT2 inhibitor approved in the Chinese market.
    the drug is an oral tablet containing 5 mg or 10 mg of dagride net, the recommended starting dose is 5 mg each time, take once a day in the morning.
    the end of October, the Forxiga (Chinese brand name: Andalton) label was updated to include data from the Landmark Cardiovascular Prognoste Study (CVOT) Phase III DECLARE-TIMI 58 study.
    is the largest and most extensive CVOT study ever conducted on SGLT2 inhibitors.
    results were published in the January 2019 New England Journal of Medicine (NEJM).
    data show that Forxiga reduces the combined risk of heart failure hospitalization (hHF) or cardiovascular (CV) death in patients with type 2 diabetes (T2D).
    original source: Forxiga approved in Japan for chronic heart failure Original title: Heavy! AstraZenega Forxiga Japan approved: the world's first SGLT2 inhibitor for heart failure!
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