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AstraZeneca announced that Anda Tang (generic name: dapagliflozin, sodium-glucose cotransporter-2 (SGLT2) inhibitor) was officially approved in the United States for the treatment of chronic kidney disease (CKD) that is at risk of disease progression In adult patients, it can reduce the associated risks including continuous decline in estimated glomerular filtration rate (eGFR), progression to end-stage renal disease (ESKD), cardiovascular (CV) death, and heart failure hospitalization (hHF)
.
This approval is based on the positive results of the DAPA-CKD Phase III trial
.
Earlier this year, the US FDA granted DAPA-CKD priority review qualification
Chronic kidney disease is a disease in which kidney function is progressively decreased, usually associated with an increased risk of heart disease or stroke, or (to the end-stage) the need for dialysis or kidney transplantation
.
It is estimated that by 2040, chronic kidney disease will become the fifth leading cause of death in the world
Professor Hiddo L.
Heerspink, Co-Chair of the DAPA-CKD Clinical Trial Executive Committee, the University of Groningen Medical Center, the Netherlands, said: "The results of the DAPA-CKD trial are groundbreaking
.
Based on this, dapagliflozin became the first approved treatment for chronic kidney disease.
Mene Pangalos, Executive Vice President of R&D of AstraZeneca Biopharmaceuticals, said: "This approval is a major advancement in the treatment of chronic kidney disease for more than 20 years
.
We have proven that dapagliflozin has significant efficacy in three therapeutic areas-type 2 Diabetes, heart failure with reduced ejection fraction, and the latest in chronic kidney disease
The DAPA-CKD trial proved that for patients with elevated urine albumin excretion in CKD 2-4, dapagliflozin compared with placebo, compared with standard treatment (ie angiotensin-converting enzyme inhibitor or angiotensin receptor blockade) On the basis of drug retardation, it can reduce the relative risk of primary composite endpoints (including deterioration of renal function, end-stage renal disease, cardiovascular or renal death) by 39% (p<0.
0001), and absolute risk (ARR) during a median follow-up of 2.
4 years Reduced by 5.
3%
.
Compared with placebo, dapagliflozin can significantly reduce the relative risk of all-cause death in patients with chronic kidney disease by 31% (ARR = 2.
DECLARE-TIMI 58 is a randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the effect of dapagliflozin on cardiovascular outcomes
.
The exploratory analysis of the study showed that dapagliflozin may also be effective for patients with early chronic kidney disease
The safety and tolerability of dagliflozin observed in the above two clinical studies are consistent with the known safety of the drug
.
In the United States, dapagliflozin has been approved to improve blood glucose control in adults with type 2 diabetes based on diet and exercise, and to reduce the hospitalization of heart failure in adults with type 2 diabetes with confirmed cardiovascular disease or multiple cardiovascular risk factors (HHF) Risk
.
Dapagliflozin is also suitable for adult patients with heart failure (HFrEF, NYHA class II-IV) with reduced ejection fraction (regardless of type 2 diabetes) to reduce their risk of cardiovascular death and hospitalization for heart failure (hHF)
