CHMP Issues Positive Opinion to Extend Invokana (Canagliflozin) Indication to Reflect Improved Renal Outcomes in Patients With Diabetic Kidney Disease and Type 2 Diabetes

- Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Phase III renal outcomes trial, which was stopped early based on a conclusive signal of efficacy in the prevention of the primary endpoint.

- If approved by the European Commission, canagliflozin will be the first therapy approved in nearly 20 years, since the approval of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs), to slow the progression of diabetic kidney disease (DKD) in UK patients with type 2 diabetes mellitus (T2DM), including those with moderate and severe renal impairment.^[1]

- There are an estimated 4.2 million people in the UK living with T2DM, approximately 40% of whom will go on to develop kidney disease.^[2],[3]

- As commercial partner to the Marketing Authorization Holder Janssen Pharmaceutica NV, Napp Pharmaceuticals Limited has exclusive distribution rights for canagliflozin in the United Kingdom.

CAMBRIDGE, England, May 29, 2020 /PRNewswire/ -- As the exclusive UK distributor of Invokana (canagliflozin), Napp Pharmaceuticals Limited today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion to extend the indication of canagliflozin to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial.^[4]

If approved by the European Commission, canagliflozin would be the only SGLT2i approved to treat diabetic kidney disease (DKD) in type 2 diabetes mellitus (T2DM) patients with an urinary albumin/creatinine ratio >300mg/g and estimated glomerular filtration rate [eGFR] down to 30ml/min/1.73m². This update will allow continued use until renal replacement therapy, recognising the cardiovascular and renal benefits of canagliflozin in T2DM even at an eGFR level <30ml/min/1.73m².^[5]

"The CHMP positive opinion is exciting news and highlights how diabetic kidney disease has become an integral part of type 2 diabetes management," said Dr Ogün Sazova, Napp Medical Director. "The opinion to extend the label to include patients who are likely to need renal replacement therapy means that Invokana will be available to slow the progression of diabetic kidney disease in this additional population of people with type 2 diabetes."