AstraZeneca’s Forxiga has been recommended for approval in the European Union for the treatment of chronic kidney disease in adults with and without Type 2 diabetes.
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. The trial showed that Forxiga (dapagliflozin), 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, and cardiovascular or renal death, compared to placebo.
Chronic kidney disease is a serious, progressive condition defined by decreased kidney function, with the most common causes being diabetes, hypertension, and glomerulonephritis. It is associated with significant patient morbidity and an increased risk of cardiovascular events, and, in its most severe form – end-stage kidney disease – kidney damage and deterioration of kidney function progress to the point where dialysis or kidney transplantation are required. Most patients with chronic kidney disease will die from cardiovascular causes before reaching end-stage kidney disease.
Treatment for chronic kidney disease
DAPA-CKD was an international, multi-centre, randomised, double-blinded Phase III trial in 4,304 patients designed to evaluate the efficacy of Forxiga 10mg, compared with placebo, in patients with chronic kidney disease, stage two to four, and elevated urinary albumin excretion, with and without Type 2 diabetes. Detailed results from the trial were published in The New England Journal of Medicine.
Forxiga significantly reduced the risk of death from any cause, compared to placebo. In the trial, the safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine. The treatment has also been indicated as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 diabetes, and for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults with and without Type 2 diabetes.
The treatment (known as Farxiga in the US) was recently approved in the US for the treatment of chronic kidney disease in adults with and without Type 2 Diabetes. It is also currently under review in Japan and other countries.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The unprecedented results of the DAPA-CKD Phase III trial show that Forxiga can significantly slow the decline of kidney function and reduce the risk of death for patients with chronic kidney disease. This positive CHMP opinion underscores Forxiga’s potential to transform the future care of chronic kidney disease and brings us one step closer to providing a much-needed new treatment option to millions of patients in the EU.”