The European Medicines Agency is considering an application to extend the licensed indication for the type 2 diabetes drug canagliflozin, an SGLT2 inhibitor, to be used in patients with stage 2 or 3 chronic kidney disease and albuminuria.
The submission to the EMA is based on results of the CREDENCE study, designed to evaluate the effect of canagliflozin on renal and cardiovascular outcomes in patients with type 2 diabetes and CKD. The trial was halted early after it became clear that the drug helped to prevent major adverse renal events.
If granted, canagliflozin will be the first drug to be licensed to treat stage 2 or 3 CKD since the introduction of ACE inhibitors and angiotensin receptor blockers for this indication in the early 2000s.
Dr Kevin Fernando, a GP at North Berwick Health Centre, RCGP Clinical Advisor for diabetes, and Primary Care Diabetes Society committee member said: ‘Diabetic kidney disease is the commonest cause of renal failure in adults starting renal replacement therapy (RRT) in the UK. We have had no new therapeutic options in primary care to slow the progression of chronic kidney disease (CKD) since the advent of ACE inhibitors or ARBs over 15 years ago.
‘The CREDENCE trial has demonstrated the compelling benefits of canagliflozin in reducing adverse outcomes in those living with T2D and co-existing CKD. This has the potential to have a significant impact on quality and quantity of life by slowing progression to ESRD requiring RRT, as well as reducing CV & renal death. We are now in a new and exciting era for managing diabetic kidney disease in primary care.’
It is estimated that between 35% and 42% of people with type 2 diabetes have diabetic kidney disease, and people with diabetes are five times more likely than those without to need renal replacement therapy.
Canagliflozin (Invokana®) and fixed dose combination canagliflozin plus metformin (Vokanamet®) are distributed in the UK by Napp Pharmaceuticals.