Shots:

• The approval is based on P-III DAPA-CKD trial evaluate Forxiga (10mg- qd) + SoC vs PBO in 4304 patients with CKD Stage 2-4 & elevated urinary albumin excretion with/out T2D
• The results showed a 39% reduction in risk of worsening of renal function- ESKD- CV- or renal death & 31% from any cause. Safety & tolerability were consistent with a safety profile of Forxiga
• The approval follows the MHLW’s PR designation granted in early 2021. The therapy was approved in the US & EU for CKD in adults with/out T2D & is currently under review in other countries globally

| Ref: AstraZeneca | Image: Mint