Posted by Michael Wonder on 22 May 2019
U.S. FDA grants priority review of Invokana (canagliflozin) sNDA for the treatment of chronic kidney disease in patients with type 2 diabetes
22 May 2019 - Application was submitted in March 2019 based on landmark phase 3 CREDENCE renal outcomes study published in the New England Journal of Medicine.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. FDA has granted priority review for the supplemental new drug application for Invokana (canagliflozin) to reduce the risk of end-stage kidney disease, the doubling of serum creatinine, and renal or cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD).
If approved for this new indication, Invokana will be the first and only diabetes medicine to treat CKD in patients with type 2 diabetes mellitus.
