NICE Recommends Forxiga for Marketing Authorization

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The UK’s NICE issued a Final Appraisal Document recommending marketing authorization for AstraZeneca’s chronic kidney disease treatment, Forxiga (dapagliflozin).

AstraZeneca announced on Feb. 3, 2022 that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Document (FAD) for Forxiga (dapagliflozin) for the treatment of chronic kidney disease (CKD) in adults. The recommendation is based on results from the DAPA-CKD Phase III trial. According to the company, it will be the first treatment for CKD in nearly 20 years and addresses an unmet need.

Dapagliflozin is recommended for the treatment of CKD in adults if it is an add-on to optimized standard care and for people that have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 at the start of treatment and have type 2 diabetes or

a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more, according to a company press release. NICE recommended removing the uACR testing restriction in people with type 2 diabetes (issued in November 2021) after a review of clinical data.


“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,” said Tom Keith-Roach, president, AstraZeneca UK, in a press release.

Source: AstraZeneca