AstraZeneca has received the European Commission (EC) approval for Forxiga (dapagliflozin) to treat chronic kidney disease (CKD) in adults, regardless of type-2 diabetes (T2D).
Forxiga is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor, with potential in preventing and delaying cardiorenal disease, along with protecting the organs.
The drug 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.
Forxiga is also indicated to improve glycaemic control in adults with T2D, in addition to diet and exercise, and to treat heart failure (HF) with reduced ejection fraction (HFrEF) in adults.
It is currently being studied in the DAPA-MI Phase 3 trial to treat patients without T2D following an acute myocardial infarction (MI) or heart attack, said the company.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos 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.”
The EC approval follows the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) positive recommendation.
The European regulator approved the drug based on positive results from Phase 3 DAPA-CKD trial in 4,304 patients with CKD Stage 2-4 and elevated urinary albumin excretion.
Forxiga, in addition to SoC treatment using an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function.
The study met the primary composite endpoint of reduction in the onset of end-stage kidney disease (ESKD), or risk of cardiovascular (CV) or renal death by 39%, compared to placebo.
Also, Forxiga significantly reduced the relative risk of death from any cause by 31%, and showed a consistent safety and tolerability with the established safety profile of the drug.
DAPA-CKD Phase 3 trial and its executive committee co-chair Hiddo Heerspink 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 3 trial, dapagliflozin delays disease progression providing physicians a critical opportunity to improve the prognosis of patients with chronic kidney disease.”
