Pharmaceutical company AstraZeneca’s treatment for chronic kidney disease has been granted approval in the EU.
AstraZeneca’s Forxiga (dapagliflozin) is an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor that has been given approval for the treatment of CKD in patients without type-2 diabetes.
The decision follows the FDA’s approval of the drug back in April 2021. The approval by the European Commission is based on a study involving over 4,000 patients and which showed that Forxiga was able to delay cardiorenal disease whilst also protecting the organs. This can be important for patients given the links between the heart, kidney and pancreas, and how damaging one of the organs can potentially cause the others to fail.
The DAPA-CKD Phase III trial showed that Forxiga 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%
CKD is a progressive condition defined by decreased kidney function and can be associated with an increased risk of heart disease or stroke. In the EU it affects around 47 million people. However, diagnosis rates can be low and patients can be unaware they have the disease.
The co-chair of the DAPA-CKD Phase III trial and its executive committee, professor Hiddo L. Heerspink, University Medical Center Groningen, the Netherlands, said: “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. 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.”
Mene Pangalos, AstraZeneca's executive vice president, BioPharmaceuticals R&D, said: “Today’s approval is an important milestone for Forxiga and has the potential to transform treatment for the millions of people living with chronic kidney disease in the EU. While new medicines like Forxiga advance the standard of care, we are also committed to the prevention and early detection of this often debilitating and life-threatening disease.”