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AstraZeneca's Forxiga (dapagliflozin) Receives EC's Approval for the Treatment of Chronic Kidney Disease in Patients with and without T2D

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AstraZeneca's Forxiga (dapagliflozin) Receives EC's Approval for the Treatment of Chronic Kidney Disease in Patients with and without T2D

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  • The approval is based on a P-III DAPA-CKD trial that evaluates the efficacy of Forxiga (10mg- qd in addition to SoC) vs PBO in 4304 patients with CKD Stage 2-4 & elevated urinary albumin excretion with & without T2D
  • The results showed 39% reduction in risk of worsening of renal function- ESKD- CV or renal death & 31% from any cause- safety & tolerability were consistent with a well-established safety profile of the therapy
  • The therapy is recently approved in the US for CKD in adults with & without T2D & is currently under review in Japan & other countries globally. The therapy is indicated as an adjunct to diet & exercise to improve glycemic control in adults with T2D & for HF with HFrEF

| Ref: AstraZeneca | Image: The Scientist Magazine

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