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
Click here to read full press release/ article | Ref: AstraZeneca | Image: Mint
The post AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for the Treatment of Chronic Kidney Disease in Patients with and without T2D first appeared on PharmaShots.
