The EC approval is based on the Phase 3 CREDENCE trial, which was stopped early after a planned interim analysis based on the achievement of a pre-specified efficacy criterion
Mundipharma secures expanded EC approval for Invokana. (Credit: Sébastien Bertrand/commons.wiki)
Mundipharma has secured the European Commission (EC) approval for the expanded indication of Invokana (canagliflozin) to include important renal outcome data from the phase 3 CREDENCE trial.
‘Canagliflozin and renal endpoints in diabetes with established nephropathy clinical evaluation’ is a Phase 3 clinical, called CREDENCE in short.
The trial evaluated renal and cardiovascular outcomes in 4401 subjects with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD) with a sodium-glucose co-transporter2 (SGLT2) inhibitor.
According to the CREDENCE trial results, canagliflozin has resulted in 30% reduction in the risk of the primary composite endpoint, comprising end-stage renal disease (ESRD), doubling of serum creatinine and renal or cardiovascular (CV) death, compared to placebo.
Mundipharma European medical affairs lead Vinicius Gomes de Lima said: “We are delighted with this extended indication granted by the European Commission, which means that patients with T2DM and kidney complications now have a new treatment option to help reduce their risk of developing kidney failure, thus potentially reducing the need for dialysis or kidney transplantation.
“The European Medicines Agency has reinforced that management of DKD should be a key treatment goal of type 2 diabetes and it is, therefore, crucial that physicians have effective treatments to help stop the progression of this life-threatening complication.”
Canagliflozin is the only approved SGLT2i in Europe to treat DKD in T2DM patients
The drug was initially approved in the European Union, in 2013, for the treatment of adults with insufficiently controlled T2DM either as monotherapy or in combination with other blood sugar-reducing medicinal products, in addition to the diet and exercise.
With the expanded EC indication, canagliflozin becomes the only approved SGLT2i to treat DKD in T2DM patients in Europe.
The regulatory approval with expanded indication enables T2DM patients in Europe with an estimated glomerular filtration rate (eGFR) between 60 and 45 mL/min/1.73m2, to receive treatment with canagliflozin 100mg.
Also, T2DM patients with albuminuria and an eGFR greater than 30 mL/min/1.73m2 are allowed for the treatment with canagliflozin 100mg and continue until dialysis or renal transplantation.