Europe extends Invokana indication to cover diabetic kidney disease in type 2 diabetes patients

pharmafile | July 3, 2020 | News story | Medical Communications, Research and Development Europe, Mundipharma, invokana 

European Commission has moved to expand the existing approved indication for Mundipharma’s Invokana (canagliflozin), making it the first sodium glucose co-transporter 2 (SGLT2) inhibitor to be approved in Europe to treat diabetic kidney disease (DKD) in type 2 diabetes (T2DM) patients.

The ruling means that the therapy will be available in a 100mg dose to T2DM patients with an estimated glomerular filtration rate (eGFR) between 60 and 45 mL/min/1.73m2.

The study comprised 4,401 participants with albuminuria and an eGFR of 30 to <90ml/min/1.73m2, all of whom had received standard of care for DKD and a maximum tolerated dose of an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARBs).

Compared to patients receiving placebo, those receiving Invokana saw a reduction of 30% in occurrence of end-stage renal disease, renal or cardiovascular (CV) death, and doubling of serum creatinine levels.

“Canagliflozin is the first medical breakthrough in nearly 20 years proven to slow the progression of chronic kidney disease in patients with diabetes at high risk of developing kidney failure,” explained Study Author Professor Vlado Perkovic, a Professorial Fellow at the George Institute and Dean of Medicine at UNSW Sydney. 

“These impressive results from the CREDENCE study have significant clinical implications for preventing kidney failure and have now been incorporated in major kidney, diabetes and cardiovascular guidelines globally. They provide an opportunity to significantly improve the health of millions of people living with chronic kidney disease and type 2 diabetes. With the new approval by The European Commission, these benefits can be realised by people across Europe.”

Matt Fellows

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