Shots:

• 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

Related News:- AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Approval of Forxiga (dapagliflozin) for Symptomatic Chronic Heart Failure