AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the European Commission for the treatment of chronic kidney disease (CKD) in the European Union (EU).
The Medicines and Healthcare products Regulatory Agency (MHRA) has similarly approved a licence extension for Forxiga in Great Britain.
The approval of dapagliflozin the first new treatment indicated for adults with CKD in nearly 20 years, AZ said in a statement.
The decision from both parties is based on positive results from the DAPA-CKD Phase III trial, which demonstrated that dapagliflozin, in addition to standard care, was the first medicine to show a significant reduction in all-cause mortality in a renal outcomes trial in patients with CKD both with and without type-2 diabetes.
The co-chair of the DAPA-CKD Phase III trial and its executive committee, Hiddo L. Heerspink, University Medical Center Groningen, the Netherlands, said: “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.”
Forxiga (known as Farxiga in the US) was recently approved in the US for the treatment of CKD in adults with and without T2D and is currently under review in Japan and several other countries around the world.