Mundipharma, the European distributor of the drug, has annouced the results of Janssen's Phase III Invokana (canagliflozin) clinical trial, demonstrating that the drug reduced the risk of renal failure, dialysis or kidney transplant and renal or cardiovascular death for patients with type II diabetes and chronic kidney disease by 30%.
As the only medicine in nearly 20 years and the first diabetes medicine to demonstrate significant reduction in risk of renal failure, dialysis or kidney transplantation and renal or cardiovascular death in this high-risk population, the data marks an important step forward in its field.
The trial, known as CREDENCE, was stopped early in July 2018 due to a signal of overwhelming efficacy in the prevention of the primary endpoint. It consisted of more than 4,400 adults with type II diabetes at 690 sites in 34 countries across North America, Latin America, Europe, South Africa and Asia Pacific.
“With nearly 24 million type II diabetes patients in Europe likely to develop diabetic kidney disease, we are delighted with the results from the CREDENCE study which demonstrated superiority of canagliflozin, when added to the standard of care,” said Dr Vinicius Gomes de Lima, european medical affairs lead.
“Type II diabetes is a growing epidemic in Europe and effective treatments are needed to help reduce the burden of the disease in patients. In particular, treatments are called for to improve renal outcomes which is of real importance in this disease.”
Invokana is an oral, once-daily medication which belongs to a class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors, which work by inhibiting SGLT2, which promotes the loss of glucose via the urine, lowering blood glucose levels in adults with type II diabetes.