Shots:

• The CHMP’s opinion is based on P-III DAPA-CKD trial evaluating the efficacy of Forxiga (10mg- qd in addition to SoC) vs PBO in 4304 patients with CKD Stage 2-4 and elevated urinary albumin excretion- with & without T2D
• Results: reduction in risk of the composite of worsening of renal function- ESKD- CV or renal death- safety & tolerability were consistent with the well-established safety profile of Forxiga
• 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