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The EC has approved the drug in the EU for treatment of chronic kidney disease in adults with or without type-2 diabetes.
On August 9, 2021, AstraZeneca announced that the European Commission (EC) approved its drug Forxiga (dapagliflozin) in the European Union for the treatment of chronic kidney disease (CKD) in adult patients with or without type-2 diabetes.
Dapagliflozin is a inhibitor of human sodium-glucose cotransporter 2 (SGLT2). In a DAPA-CKD Phase III trial, it was demonstrated that dapagliflozin, in addition to standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, “reduced the relative risk of worsening of renal function, onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39% (the primary composite endpoint), compared to placebo (absolute risk reduction [ARR]=5.3%, p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion,” according to a company press release.
CKD is a condition where kidneys do not function optimally. It is estimated that 840 million people worldwide and 47 million in the EU have CKD. However, diagnosis rates are low, with up to 90% of affected individuals not knowing they have the condition.
“Today’s approval establishes dapagliflozin as the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status in the EU,” said Hiddo L. Heerspink, a professor at University Medical Center Groningen, the Netherlands, in the company press release. “Based on the unprecedented results from the DAPA-CKD Phase III trial, dapagliflozin delays disease progression providing physicians a critical opportunity to improve the prognosis of patients with chronic kidney disease.”