Dagle's net listing application receives FDA priority review
Release date: 2020-01-07 Views: 0
On January 6, AstraZeneca announced that the U.S. FDA has accepted Farxiga (dapagliflozin) supplemental new drug application (sNDA) and granted priority review qualification for reducing heart failure with ejection fraction Reduce the risk of cardiovascular death (CV) or worsening heart failure (HF) in adults (with or without type 2 diabetes, T2D). The PDUFA for this supplementary new drug application (sNDA) is set for the second quarter of 2020. In September 2019, the FDA granted Farxiga fast-track qualification for the treatment of heart failure (HF); in August 2019, the FDA granted Farxiga to delay the progression of renal failure in patients with chronic kidney disease (with or without T2D) and prevent adult cardiovascular (CV) ), Fast-track eligibility for kidney death. Farxiga is mature in the treatment of type 2 diabetes, and this priority review shows its potential to affect millions of patients with heart failure. If approved, Farxiga will be the first and only drug of its kind to treat patients with heart failure (HF).
The sNDA application is based on the results of the Phase 3 clinical trial of DAPA-HF, which was published in the New England Journal of Medicine in September 2019. DAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is a An international, multicenter, parallel, randomized, double-blind trial in patients with or without T2D in heart failure with reduced ejection fraction (LVEF≤40%), designed to evaluate Farxiga 10mg compared to placebo, In addition to standard treatment, it is administered once daily. The primary composite endpoint was the time to the first occurrence of a worsening heart failure event (hospitalization or equivalent; that is, an emergency heart failure visit) or cardiovascular death. The trial showed that compared with placebo, Farxiga combined with standard treatment reduced the incidence of CV deaths or HF worsening composite outcomes.
Daglipine is a "first-in-class" oral sodium-glucose cotransporter 2 (SGLT2) inhibitor. SGLT2 is a transporter in the kidney that assists glucose reabsorption. SGLT2 inhibitors reduce the level of glucose in the blood by inhibiting the function of SGLT2, allowing more glucose to be excreted from the urine. Previously, dalaglipeline has been approved by the FDA to work with diet and exercise to improve glycemic control in people with type 2 diabetes and reduce their weight and blood pressure. It is also approved by the European Union for the treatment of patients with type 1 diabetes; in October 2019, the FDA also approved Farxiga for reducing the risk of hospitalization for heart failure in T2D patients who have been identified with cardiovascular disease or multiple CV risks factor.
Heart failure (HF) is a life-threatening disease, and the heart cannot pump enough blood to the entire body. It affects approximately 64 million people worldwide (at least half of the patients have reduced ejection fraction), is a chronic degenerative disease, and half of the patients will die 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 cause of hospitalization for elderly people over 65 years of age and causes severe clinical and financial burdens.
Source: Instant Medicine Smell
 Farxiga granted FDA Priority Review for patients with heart failure with reduced ejection fraction. Retrieved 2020-01-06, from http://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-granted- fda-priority-review-for-patients-with-heart-failure-with-reduced-ejection-fraction-06012020.html #!
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- 达格列净上市申请获FDA优先审查 7. Dagle's net listing application receives FDA priority review