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Farxiga CKD trial early stop for positive efficacy
Farxiga CKD trial early stop for positive efficacy.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n RNS Number : 0048I\n AstraZeneca PLC\n 30 March 2020\n \n \n \n \n 30 March 2020 07:00 BST\n \n \n \n \n \n \n Farxiga\n \n \n Phase III DAPA-CKD trial will be stopped early after\noverwhelming efficacy in patients with chronic kidney disease\n \n \n \n \n \n \n Farxiga is the first SGLT2 inhibitor to show meaningful benefit in patients with chronic kidney disease in a trial including both type-2 diabetics and non-diabetics\n \n \n \n \n \n The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for Farxiga (dapagliflozin) in patients with chronic kidney disease (CKD) will be stopped early following a recommendation from an independent Data Monitoring Committee (DMC) based on its determination of overwhelming efficacy.\n \n \n \n \n \n The decision to stop the trial early was made following a routine assessment of efficacy and safety which showed Farxiga's benefits earlier than originally anticipated and AstraZeneca will now initiate closure of the trial.\n \n \n \n \n \n Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: \"\n Chronic kidney disease patients have limited treatment options, particularly those without type-2 diabetes. We are very pleased the Data Monitoring Committee concluded that patients experienced overwhelming benefit. Farxiga has the potential to change the management of chronic kidney disease for patients around the world.\"\n \n \n \n \n \n The co-chairs of the trial and its Executive Committee Prof. David Wheeler, University College London, and Prof. Hiddo L. Heerspink, University Medical Center Groningen, said: \"It has been a privilege to be involved in this trial. We are delighted with the Data Monitoring Committee recommendation and look forward to sharing the results with the medical community and patients with chronic kidney disease.\"\n \n \n \n \n \n The primary endpoint of DAPA-CKD is a composite of worsening of renal function or death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), onset of end-stage kidney disease (ESKD) or cardiovascular (CV) or renal death) in patients with CKD irrespective of the presence of type-2 diabetes (T2D).1\n \n \n \n \n \n The full results will be submitted for presentation...