AstraZeneca’s Forxiga (dapagliflozin) Receives EU Approval for the treatment of Symptomatic Chronic Heart Failure
- The approval was based on the P-III trial (DELIVER) evaluating Forxiga vs PBO in 6263 HF patients with LVEF ≥40% with/out T2D. The primary composite EPs were the time to the first occurrence of CV death, hHF, or an urgent HF visit. & 2EPs incl. the total no. of HF events & CV death, change from baseline in the total symptom score of KCCQ @8mos., time to the occurrence of CV death & death from any cause
- Forxiga was found to be 1st HF drug to show a mortality benefit across the full ejection fraction range in the prespecified pooled analysis of the P-III (DELIVER) & (DAPA-HF) trials
- Forxiga was approved in 100+ countries globally for T2D, HFrEF & CKD incl. the US, the EU, China & Japan. The therapy has received regulatory approvals in Great Britain, Japan & Turkey
Ref: AstraZeneca | Image: AstraZeneca
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