The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) recommending AstraZeneca’s Forxiga (dapagliflozin) within its marketing authorisation for the treatment of adults with chronic kidney disease (CKD). The FAD forms the basis of the final guidance that NICE issues to the NHS.

It is a decision that will give eligible patients access to the first treatment option indicated for CKD in nearly 20 years.

“I am thrilled by this decision from NICE, as this expanded recommendation is going to have a genuine impact on the way that kidney doctors and GPs can treat their patients,” said Professor James Burton, Professor of Renal Medicine and Honorary Consultant Nephrologist, University of Leicester.

CKD is a long-term condition, in which the kidneys do not function properly and are unable to remove waste products from the body. At advanced stages of the disease, this can result in tiredness, swollen ankles, feet and hands, shortness of breath and blood in the urine.

Approximately one in ten people are estimated to be affected by CKD in the UK, resulting in an estimated 40,000 to 45,000 premature deaths every year.

Meanwhile, around 1 million in England are estimated to be living with the condition undiagnosed. CKD accounts for a significant burden on the UK healthcare system, making up 1.3% of NHS spending.

“For the first time in almost two decades, eligible people living with chronic kidney disease will have access to a new treatment option that has been shown to slow kidney decline and potentially delay transplant or dialysis. Given the impact those treatments can have on the quality of life of patients and those around them, this represents a significant milestone for many people living with kidney disease,” Professor Burton added.