NICE issues FAD for Forxiga in adults with chronic kidney disease

pharmafile | February 4, 2022 | News story | Medical Communications  

NICE has issued a Final Appraisal Document (FAD) recommending Forxiga (dapagliflozin) within its marketing authorisation for the treatment of adults with chronic kidney disease (CKD).

Dapagliflozin is recommended as an option for treating CKD in adults. It is recommended only if it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated.

CKD is a long-term condition where the kidneys are unable to remove waste products from the body. It is estimated that one in ten people are affected by CKD in the UK, and there are an estiated 40,000-45,000 premature deaths every year due to the condition. The disease represents a significant burden on the UK healthcare system, and accounts for 1.3% of NHS spending overall.

Professor James Burton, Professor of Renal Medicine and Honorary Consultant Nephrologist, University of Leicester, said: “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. 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.”

Tom Keith-Roach, President, AstraZeneca UK: “This final recommendation from NICE is a watershed moment for people living with CKD, providing access to a new treatment option, which has the potential to change the way CKD is managed. We will work closely with NICE and the NHS to pull this through into clinical practice, supporting earlier identification of CKD to prevent disease progression and potentially defer the need for life-altering treatments like dialysis.”

Lina Adams

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