Mundipharma has announced that the European Medicines Agency (EMA) has accepted the licence extension submission for Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin) to treat stage two or stage three chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type II diabetes mellitus.
The decision is based on results from the landmark Phase III CREDENCE study which evaluated the efficacy and safety of Invokana versus placebo in the high-risk patient population, when used in addition to standard of care.
The drug is already approved in Europe for adults with insufficiently controlled T2DM as an adjunct to diet and exercise, with an initiation dose of 100mg once daily in adults with an eGFR of ≥ 60 mL/min/1.73 m2. The company announced that the dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability, using the recommended daily dose of 100 mg or 300 mg Invokana and not exceeding the maximum recommended daily dose of metformin orally.
“Chronic kidney disease is a serious complication of type II diabetes, which can increase patients’ risk of developing end-stage renal disease and may reduce their life expectancy by several years.” said Dr Vinicius Gomes de Lima, european medical affairs lead, Mundipharma. “If approved, this licence extension would be a significant step forward to help reduce the associated burden of chronic kidney disease and improve patients’ quality of life.”
Approximately 24 million type II diabetes mellitus patients in Europe are likely to develop diabetic kidney disease. It has a major impact on patients’ physical, emotional and financial wellbeing and amplifies the risk of diabetes complications including; cardiovascular disease, a reduced quality of life, infections, fatigue, depression, adverse drug reactions and premature death.