New chronic kidney disease (CKD) study indicates that CKD is present in one out of ten adults
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Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease
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for the treatment of patients with chronic kidney disease
for millions of people in the EU suffering from chronic kidney disease AstraZeneca s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease (ESKD) and cardiovascular (CV) or renal death, compared to placebo.
disease in patients at risk of progression with and without type-2 diabetes
of chronic kidney disease in more than 20 years
In DAPA-CKD Phase III trial, Farxiga demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death
AstraZeneca s Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression.
The approval by the Food and Drug Administration (FDA) was based on positive results from the DAPA-CKD Phase III trial. The decision follows the Priority Review designation granted by the FDA earlier this year.