Shots:
- The acceptance of regulatory submission and the granting of PR is based on P-III DAPA-CKD study assessing Farxiga (10mg, qd) + SOC vs PBO in 4,304 patients with CKD stages 2-4 and elevated urinary albumin excretion, with/ out T2D
- The study demonstrated that the therapy reduced the risk of the composite of worsening of renal function or risk of CV or renal death by 39% and reduction in the risk of death from any cause by 31%. The safety & tolerability is consistent with the known safety profile of the therapy
- Farxiga is an SGLT2 inhibitor and has received the US FDA’s BTD for CKD with/ out T2D. The anticipated PDUFA date for the therapy is Q2’21
Click here to read full press release/ article | Ref: AstraZeneca | Image: Nutralngredients-Asia
The post AstraZeneca’s Farxiga (dapagliflozin) Receives the US FDA’s Priority Review for Chronic Kidney Disease first appeared on PharmaShots.
