Mundipharma Announces the Licence Extension Submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to the European Medicines Agency
- The licence extension submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to treat type 2 diabetes mellitus (T2DM) patients with chronic kidney disease (CKD) will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP)
- The CREDENCE renal outcomes study, which was stopped early due to positive efficacy findings, served as the basis for the licence extension submission
- If approved, Invokana will be the first therapy in nearly 20 years indicated to reduce the risk of end-stage renal disease when added to current standard of care for this group of T2DM patients
- Mundipharma has a partnership with Janssen to be the exclusive distributor for Invokana across 18 countries in the European Economic Area (EEA) and Switzerland where the products currently have Pricing and Reimbursement status. This is with the exception of Spain, where the products are co-promoted by both Janssen and Mundipharma
CAMBRIDGE, UK: 22.08.19 – As the European distributor of Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin), Mundipharma welcomes the news that the European Medicines Agency (EMA) has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus (T2DM). The submission is based on the results from the landmark Phase III CREDENCE study which evaluated the efficacy and safety of canagliflozin versus placebo in this high-risk patient population when used in addition to standard of care.
“Chronic kidney disease is a serious complication of type 2 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 T2DM patients in Europe are likely to develop diabetic kidney disease (DKD), which is projected to rise in line with the increasing prevalence of diabetes. DKD 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.
In Europe, Invokana is currently indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise. The initiation dose is 100mg once daily in adults with an eGFR of ≥ 60 mL/min/1.73 m2 and can be increased to 300mg once daily orally if tighter glycaemic control is needed. Canagliflozin should not be initiated if eGFR is < 60 mL/min/1.73 m2. In patients tolerating canagliflozin whose eGFR falls persistently below 60 mL/min/1.73 m2 the dose should be adjusted to or maintained at 100mg once daily. Canagliflozin should be stopped if eGFR falls persistently below 45 mL/min/1.73 m2.
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 canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.
Invokana and Vokanamet have been approved in the European Union since 2013 and 2014 respectively. In July 2018, the treatment labels were updated to include positive cardiovascular and renal outcomes from the CANVAS programme which show a reduction in morbidity and mortality.