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    Home > Medical News > Latest Medical News > Dapagliflozin's listing application receives FDA priority review

    Dapagliflozin's listing application receives FDA priority review

    • Last Update: 2020-01-07
    • Source: Internet
    • Author: User
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    On January 6, AstraZeneca announced that the FDA of the United States has accepted the application for additional new drugs (SNDA) from farxiga (dapagliflozin, daggliflozin) and granted it the priority qualification for examination to reduce the risk of cardiovascular (CV) death or heart failure (HF) deterioration in adults with or without type 2 diabetes mellitus (T2D) in patients with heart failure and reduced ejection fraction The PDUFA date for this SNDA supplement is set for the second quarter of 2020 In September 2019, the FDA granted farxiga the fast track qualification to treat heart failure (HF); in August 2019, the FDA granted farxiga the fast track qualification to delay the progression of renal failure in patients with chronic kidney disease (with or without T2D) and prevent cardiovascular (CV) and renal death in adults Farxiga is well established in the treatment of type 2 diabetes, and this priority review shows its potential to affect millions of people with heart failure If approved, farxiga will be the first and only drug of its kind to treat patients with heart failure (HF) This SNDA application is based on the results of clinical phase 3 dapa-hf trial, which was published in September 2019 in the New England Journal of medicine Dapa-hf (dapagliflozin and prevention of advocate outcome in heart failure) is an international, multicenter, parallel group, randomized, double-blind trial conducted in patients with or without T2D with reduced ejection fraction (LVEF ≤ 40%) In the evaluation of farxiga 10mg compared with placebo, in addition to standard treatment, once a day The primary composite end point was the time to the first worsening event of heart failure (hospitalization or equivalent; i.e., emergency heart failure visit) or cardiovascular death The trial showed that farxiga combined with standard therapy reduced the incidence of CV death or HF worsening composite outcomes compared to placebo Dagliejing is a "first in class" oral sodium glucose cotransporter 2 (SGLT2) inhibitor SGLT2 is a transport protein in the kidney that assists in the reabsorption of glucose SGLT2 inhibitors reduce blood glucose levels by inhibiting the function of SGLT2 and allowing more glucose to be excreted from urine Previously, dagrinine had been approved by the FDA to improve blood glucose control in type 2 diabetes patients, along with diet and exercise, and to reduce their weight and blood pressure It has also been approved by the European Union to treat patients with type 1 diabetes; in October 2019, the FDA also approved farxiga to reduce the risk of hospitalization for heart failure in T2D patients who have been identified as having cardiovascular disease or multiple CV risk factors Heart failure (HF) is a life-threatening disease The heart cannot pump enough blood to the whole body It affects about 64 million people worldwide (at least half of whom have a reduced ejection fraction), and is a chronic degenerative disease, with half dying within five years of diagnosis In men (prostate and bladder cancer) and women (breast cancer), HF is as lethal as some of the most common cancers It is the main reason for the elderly over 65 years old to be hospitalized, and causes serious clinical and economic burden Reference: [1] farxiga granted FDA priority review for patients with heart failure with reduced expectation fraction Retrieved 2020-01-06, from https://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-granted-fda-priority-review-for-patients-with-heart-failure-with-reduced-expectation-fraction-06012020.html
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