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NICE recommends AZ’s Forxiga for kidney disease

The recommendation is based on results from a phase 3 trial


AstraZeneca has announced that the National Institute for Health and Care Excellence (NICE) has recommended Forxiga (dapagliflozin) for the treatment of adults with chronic kidney disease (CKD).

This decision will give eligible patients diagnosed with CKD access to the first treatment pathway in nearly 20 years.

NICE’s most recent decision follows its draft recommendation – issued in November 2021 – which removed the urine albumin-to-creatinine ratio (uACR) testing restriction in the type 2 diabetes population, allowing increased access for patients in need of treatment.

CKD is a long-term condition where the patient’s kidney function is severely reduced, affecting the kidney’s ability to remove waste products from the body. The condition is a considerable burden on the UK healthcare system, representing 1.3% of NHS spending in total.

The DAPA-CKD phase 3 trial formed the basis of NICE’s recommendation, which demonstrated that dapagliflozin, in addition to standard care, proved to be more effective than placebo plus standard of care in adult patients with or without type 2 diabetes.

While it is estimated that one in ten people are impacted by CKD in the UK – totalling in around 40,000–45,000 premature deaths every year –  AstraZeneca estimates that there could be approximately 373,000 adults living with the condition who could qualify for Forxiga treatment in England, Wales and Northern Ireland.

These statistics are particularly significant to minority ethnic groups including Black and Asian communities because these groups are not only fives times more susceptible to developing CKD than other groups, but are also less likely to access certain treatments, including transplantation.

NICE’s decision furthers the progress of available medical treatment for CKD, addressing the unmet needs for patients suffering with the condition.

Tom Keith-Roach, president of AstraZeneca UK, said: “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.”

Article by
Fleur Jeffries

3rd February 2022

From: Regulatory



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