AstraZeneca’s Forxiga (dapagliflozin) Receives the NMPA’s Approval for Adult Patients with Symptomatic Chronic Heart Failure
- The NMPA has approved Forxiga to reduce the risk of CV death, hospitalization for HF, or urgent HF visits in adults with symptomatic chronic HF. The approval was based on the P-III trial (DELIVER) evaluating Forxiga vs PBO in 6263 patients with LVEF above 40% with/out T2D
- The results showed that Forxiga met its 1EPs in reducing the composite outcome of CV death or worsening HF by 18% vs 19.5% over a median follow-up of 2.3yrs. The prespecified pooled analysis of the P-III (DELIVER) and (DAPA-HF) trials also established dapagliflozin as the first HF medication to demonstrate a mortality benefit across the full ejection fraction range
- Forxiga was also approved for T2D, HFrEF & CKD in 100+ countries globally incl. China, Japan, the US, and the EU
Ref: AstraZeneca | Image: AstraZeneca
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