The Janssen Pharmaceutical Companies of Johnson & Johnson announced that following a Priority Review, Health Canada has approved Invokabna (canagliflozin) as an adjunct to diet, exercise, and standard-of-care therapy, to reduce the risk of end-stage kidney disease (ESKD), doubling of serum creatinine, and cardiovascular (CV) death in adult patients with type 2 diabetes mellitus and diabetic nephropathy (also known as diabetic kidney disease) with albuminuria (>33.9mg/mmol).
The new indication is based on results from the landmark Phase III CREDENCE study, the first dedicated renal outcomes study of any sodium-glucose co-transporter 2 (SGLT2) inhibitor in patients with type 2 diabetes and diabetic nephropathy. In CREDENCE, Invokana added to standard-of-care therapy demonstrated a 30 per cent reduction in the risk of the primary composite endpoint, comprised of end-stage kidney disease (ESKD), doubling of serum creatinine and renal or CV death, compared to standard-of-care therapy alone. Results also showed Invokana reduced the risk of secondary CV endpoints, including a 31 per cent reduction in the risk of the composite of CV death or hospitalization for heart failure, a 20 per cent reduction in MACE (major adverse cardiovascular events; composite of CV death, nonfatal myocardial infarction [MI] and nonfatal stroke), and a 39 per cent reduction in the risk of hospitalization for heart failure alone. Importantly, the study showed no imbalance in lower limb amputations or bone fractures and no new safety concerns were identified in this study of high-risk renal patients.
This is an important advancement given the increased prevalence of diabetic kidney disease in those living with type 2 diabetes," said Adeera Levin, M.D., F.R.C.P.C., F.A.C.P., C.M., Head, Division of Nephrology, Professor of Medicine, University of British Columbia, Executive Director, BC Provincial Renal Agency and CREDENCE National Lead Investigator for Canada. "With this new indication for Invokana, physicians are now able to offer a treatment option that reduces the cardiovascular and kidney risks associated with diabetic kidney disease."