EMA accepts license extensions from Invokana and Vokanamet

Mundipharma announced that the European Medicines Agency (EMA) had received a deferred licence from Invokana and Vokanamet (canagliflozin and metformin) for the treatment of stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as standard assisted type 2 diabetes patients.The decision is based on the results of the landmark Phase III CREDENCE study, which assessed the effectiveness and safety of Invokana and placebo in high-risk patient groups when used in standard treatments.Europe has approved the drug for the control of T2DM deficiency in adults, as an aid of diet and exercise, adult eGFR≥60mL / minute / 1.73 m2, the initial dose is once daily, 100 mg. The company announced that Vokanamet's sugar-lowering therapeutic dose should be individualized according to the patient's current treatment regimen, effectiveness and tolerance, using the recommended daily dose of 100 mg or 300 mg Invokana, and not exceeding the recommended maximum daily dose of metformin orally.“ Chronic kidney disease is a serious complication of type 2 diabetes that can increase a patient's risk of developing end-stage kidney disease and may shorten their life expectancy by several years. Dr Mundipharma, Head of Medical Affairs in Europe, Dr Vincius Gomes de Lima, said: "If approved, this extension of the licence would be an important step forward in helping to reduce the associated burden of chronic kidney disease and improve the quality of life of patients. About24 million people with type 2 diabetes in Europe are at risk of developing diabetic nephropathy. This has a significant impact on the physical, emotional and economic well-being of patients and increases the risk of complications from diabetes, including cardiovascular disease, decreased quality of life, infection, fatigue, depression, adverse drug reactions and premature death. （cyy123.com)