dapagliflozin
Metabolic· 2783 cited findings· 3 source documents
Company: AstraZeneca PLC →
What the regulatory reviews say
Dapagliflozin is a drug that received EU approval in November 2012 (FORXIGA). Fixed-dose combinations, XIGDUO FDC and EBYMECT FDC, were approved in the EU on 16 January 2014 and 16 November 2015, respectively. A Type II variation application was submitted on 8 January 2019.
In a Phase IIIb trial, dapagliflozin (10 mg) demonstrated a Hazard Ratio (HR) of 0.83 (95% CI: 0.73, 0.95; p=0.005) for the composite of hospitalisation for heart failure and cardiovascular death when compared to placebo. For a renal composite endpoint, the HR was 0.76 (95% CI: 0.67, 0.87; p<0.001) versus placebo. The HR for Major Adverse Cardiovascular Events (MACE) was 0.93 (95% CI: 0.84, 1.03; p=0.172) compared to placebo. All-cause mortality had an HR of 0.93 (95% CI: 0.82, 1.04; p=0.198) versus placebo.
Safety data indicated that 0.5% of patients experienced DAEs due to Urinary tract infection (OT-SAS). Total exposure to dapagliflozin was 30623 patient-years, with a median duration of exposure to the study drug of 48 months.
Key figures — cited to the source page
| HR for Hospitalisation for HF/CV death (dapagliflozin vs placebo) | 0.83 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.22 |
| 95% CI for Hospitalisation for HF/CV death HR (dapagliflozin vs placebo) | 0.73, 0.95 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.22 |
| p-value for Hospitalisation for HF/CV death HR (dapagliflozin vs placebo) | 0.005 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.22 |
| HR for Renal composite endpoint (dapagliflozin vs placebo) | 0.76 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.22 |
| 95% CI for Renal composite endpoint HR (dapagliflozin vs placebo) | 0.67, 0.87 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.22 |
| p-value for Renal composite endpoint HR (dapagliflozin vs placebo) | <0.001 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.22 |
| DAEs due to Urinary tract infection (OT-SAS) | 0.5 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.66 |
| Dapagliflozin EU approval date (FORXIGA) | November 2012 | AstraZeneca PLC — Ebymect EMA EPAR variation assessment repo, p.7 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.