Invokana filed with FDA for end-stage kidney disease in type 2 diabetes
Janssen has submitted a supplemental New Drug Application (sNDA) to the FDA for a new indication for Invokana (canagliflozin), aiming to cut the risk of end-stage kidney disease, the doubling of serum creatinine, which is a key predictor of end stage kidney disease, and renal or cardiovascular (CV) death in adults with type II diabetes and chronic kidney disease.
The submission is based on results from the Phase III CREDENCE study. This trial was halted early due to positive efficacy findings. If approved, it will be the first therapy indicated to reduce the risk of end-stage kidney disease when added to current standard of care.
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