EMA approves extension of approval for Invokana and Vokanamet for chronic kidney disease and albuminuria in type 2 diabetes

The European Medicines Agency has accepted the licence extension submission for Invokana (canagliflozin) and Vokanamet (canagliflozin and metformin), from Mundipharma, to treat stage two or stage three chronic kidney disease and albuminuria as an adjunct to standard of care in adults with type II diabetes mellitus. The decision is based on results from the 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.

Canagliflozinis already approved in Europe for adults with insufficiently controlled type II diabetes as an adjunct to diet and exercise, with an initiation dose of 100mg once daily in adults with an eGFR of at least 60 mL/min/1.73 m2. According to Mundipharma, the dose of glucose-lowering therapy with Vokanamet should be determined 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.