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

 ­ Ref: AstraZeneca | Image: New Europe