Posted by Michael Wonder on 01 Jun 2020
CHMP issues positive opinion to extend Invokana (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes
29 May 2020 - Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Phase III renal outcomes trial, which was stopped early based on a conclusive signal of efficacy in the prevention of the primary outcome.
As the exclusive UK distributor of Invokana (canagliflozin), Napp Pharmaceuticals today announced that the EMA's CHMP has adopted a positive opinion to extend the indication of canagliflozin to include important renal outcome data from the landmark Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial.
