AstraZeneca PLC — Edistride EMA EPAR variation assessment report (EMEA/H/C/004161, 2015)
AstraZeneca PLC · 2015 · EMA EPAR variation assessment report · company profile →
Report summary
AstraZeneca AB submitted a Type II variation for dapagliflozin (Forxiga/Edistride) to extend its heart failure (HF) indication to patients with LVEF > 40%. The application is based on the Phase III DELIVER study (6263 patients), which compared dapagliflozin 10 mg to placebo. A pooled analysis with the DAPA-HF study was also conducted. DELIVER demonstrated dapagliflozin's superiority in reducing cardiovascular death and HF events (HR 0.82, p=0.0008), with consistent efficacy across primary and secondary endpoints, including improved KCCQ scores. Baseline characteristics were balanced, and the study's integrity was minimally affected by COVID-19. Safety profiles were balanced between groups, with low rates of major adverse events and no new safety concerns identified. The benefit-risk assessment for dapagliflozin in HF with preserved ejection fraction (HFpEF) is positive.
Key findings — cited to the page
| Population for DELIVER | patients with HF and LVEF > 40% | DELIVER (D169CC00001) · p.7 |
| Hospitalisations due to HF in Westernised countries | 1% to 4% | Westernised countries · p.8 |
| Dapagliflozin approval for T2DM | 2012 | · p.7 |
| Study name | DELIVER (D169CC00001) | · p.7 |
| Prevalence of known HF in general adult population | 1% to 2% | · p.8 |
| HF with LVEF > 40% accounts for | approximately half | · p.8 |
| Annual hospitalisations for HF | well over 1 million | United States, Europe · p.8 |
| Primary endpoint | composite of CV death or an HF event (hospitalisation for HF or urgent HF visit) | DELIVER (D169CC00001) · p.6 |
| Study name | DAPA-HF (D1699C00001) | · p.7 |
| Population for DAPA-HF | HFrEF (LVEF ≤ 40%) | DAPA-HF (D1699C00001) · p.7 |
| Estimated people affected by HF worldwide | 64 million | Global · p.8 |
| Readmissions after hospitalisation for LVEF > 40% within first year | 28% to 45% | · p.8 |
Source: AstraZeneca PLC ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →