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Janssen's Invokana (canagliflozin) Receives the US FDA's Approval for Patients with Type 2 Diabetes and Diabetic Kidney Disease

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Janssen's Invokana (canagliflozin) Receives the US FDA's Approval for Patients with Type 2 Diabetes and Diabetic Kidney Disease

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  • The approval is based on P-III CREDENCE study evaluating the renal outcomes of Invokana + SoC vs PBO in 4-401 patients with T2D with stage II/III DKD and macroalbuminuria who were receiving SoC including ACE inhibitors & ARB
  • The P-III CREDENCE study resulted in 30% reduction in 1EPs i.e- end-stage kidney disease (ESKD)- doubling of serum creatinine and renal or CV death along with the 39% reduction in the risk of hospitalization for HF
  • Invokana is an SGLT2 inhibitor indicated to lower blood glucose level in T2D adjunct to diet & exercise- to reduce CV events & risk of ESKD & is only therapy for T2D to treat DKD & risk of hospitalization for HF in patients with T2D & DKD

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Ref: Janssen | Image: Janssen


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