AstraZeneca Receives EMA’s CHMP Positive Opinion Recommending Approval of Forxiga (dapagliflozin) for Symptomatic Chronic Heart Failure
Shots:
- The EMA’s CHMP positive opinion was based on the P-III (DELIVER) trial evaluating Forxiga vs PBO in 6263 patients with HF with LVEF ≥40% with/out T2D
- The results showed a 16.4% vs 19.5% reduction in the composite outcome of CV death or worsening of HF in patients with HFpEF & HFmrEF over a median follow-up of 2.3yrs. The treatment effect was consistent across the LVEF range without evidence of attenuation of effect by LVEF & the results were published in The NEJM
- In the pre-specified, patient-level, pooled analysis, Forxiga showed a 14% reduction in risk of CV death, death from any cause (10%) & total hHF (29%) over the median follow-up of 22mos. Forxiga was approved for HFrEF in 100+ countries globally incl. the US, the EU, China & Japan
Ref: AstraZeneca | Image: AstraZeneca
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