dapagliflozin (Forxiga)

following a full submission:

dapagliflozin (Forxiga®) is accepted for restricted use within NHSScotland.

Indication under review: in adults for the treatment of chronic kidney disease.

SMC Restriction:

• in patients with an estimated glomerular filtration rate of ≥25 to ≤75 mL/min/1.73m² at treatment initiation, and
• are receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker (unless these are not tolerated or contraindicated), and
• have a urine albumin creatinine ratio of at least 23mg/mmol, or type 2 diabetes mellitus or both.

In a randomised, double-blind, phase III study in patients with chronic kidney disease, treatment with dapagliflozin added to standard of care significantly reduced the risk of first occurrence of ≥50% sustained decline in estimated glomerular filtration rate, end stage renal disease, cardiovascular death or renal death when compared with standard of care alone.