Treatment approved in EU for chronic kidney disease in people living with – and without - type 2 diabetes
Recent trials suggest SGLT2 inhibitor could be the most significant development in treating chronic kidney disease in more than 20 years.
A sodium-glucose cotransporter 2 (SGLT2) inhibitor treatment has been approved in the European Union (EU) for the treatment of chronic kidney disease in adults living with and without type 2 diabetes.
The approval of AstraZeneca’s Forxiga (dapagliflozin) by the European Commission is based on positive results from the recent studies. The decision follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Chronic kidney disease is a serious, progressive condition defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke. It affects 840 million people worldwide and approximately 47 million in the EU. However, diagnosis rates remain low and up to 90% of patients are unaware they have the condition.
Professor Hiddo L. Heerspink of the University Medical Center Groningen, in the Netherlands, and Co-Chair of the study said: “This 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, Executive Vice President, BioPharmaceuticals R&D, said: “This 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 study found that Forxiga reduced the relative risk of worsening of renal (kidney) function, onset of end-stage kidney disease, or risk of cardiovascular (heart) or renal death by 39%, compared to tests with a placebo.
Forxiga also significantly reduced the relative risk of death from any cause by 31%, compared to a placebo treatment. The safety and tolerability of Forxiga was consistent with the well-established safety profile of the medicine.
Forxiga (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 and is currently under review in Japan and several other countries around the world. Forxiga is also indicated as an adjunct to diet and exercise to improve glycaemic (blood glucose) control in adults with type 2 diabetes and for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults regardless of diabetes status.
Bethany Kelly, Diabetes Specialist Nurse at Solent NHS Trust and DRWF Editorial Advisory Board member, said: “Dapagliflozin or Forxiga is a drug from the SGLT2 inhibitor drug group.
Diabetes specialist teams have been using this drug for people living with type 2 diabetes, as well as other types of SGLT2 inhibitor medications for a good eight years or more.
“Forxiga is a drug that works by stopping the kidneys from reabsorbing glucose back into the blood. This allows the kidneys to reduce blood glucose levels as the remaining glucose is removed from the body in your urine. Forxiga is known to help people lose weight and manage glucose levels, but can also rarely cause increased urination, dehydration, urinary infections and episodes of thrush.
“This new data shows how good this drug can be at prevention and treatment of kidney disease. Forxiga has a licence for the treatment of heart failure, type 1 and type 2 diabetes and now, this new licence means that we can now use this medication in people with kidney disease and with a low renal function, but who do not have a diagnosis of diabetes. Therefore, this is no longer just a drug for diabetes, but also for cardiovascular and kidney health too.”