Farxiga(dapagliflozin)
Metabolic· 3069 cited findings· 4 source documents
Company: AstraZeneca PLC →
What the regulatory reviews say
Farxiga (dapagliflozin) is an efficacy supplement (sNDA 202293 S26) for NDA 202293. It is available in 5 mg and 10 mg tablet strengths. The DELIVER trial, which included 3126 patients treated with 10 mg dapagliflozin and had a planned sample size of 4500 patients, investigated its effects in patients with LVEF >40%.
Key efficacy findings include a mean change in KCCQ-TSS from baseline at 8 months of 8.3, compared to 5.2 for placebo, with a KCCQ-TSS win ratio of 1.11 (95% CI: 1.03, 1.21; p-value: 0.009). The hazard ratio for the composite of hospitalization for heart failure or CV death was 0.83, and for hospitalization for heart failure alone was 0.73. There was an adjusted mean body weight change from baseline of -0.1.
Safety data indicate an all-cause mortality hazard ratio of 0.94 (95% CI: 0.83, 1.07; p-value: 0.3). The incidence of applicant-defined amputations was 0.6% and 0.8%. There were 12 potential DKA events in the dapagliflozin group compared to 7 in the placebo group.
Key figures — cited to the source page
| Mean change in KCCQ-TSS from baseline at 8 months | 8.3 | Farxiga FDA Review (NDA/BLA 202293, 2023), p.113 |
| Mean change in KCCQ-TSS from baseline at 8 months (placebo) | 5.2 | Farxiga FDA Review (NDA/BLA 202293, 2023), p.113 |
| KCCQ-TSS win ratio | 1.11 | Farxiga FDA Review (NDA/BLA 202293, 2023), p.113 |
| Hazard ratio for composite of hospitalization for heart failure or CV death | 0.83 | Farxiga FDA Review (NDA/BLA 202293, 2021), p.44 |
| All-cause mortality Hazard Ratio | 0.94 | Farxiga FDA Review (NDA/BLA 202293, 2023), p.113 |
| Amputations (Applicant-defined) incidence | 0.6 | Farxiga FDA Review (NDA/BLA 202293, 2023), p.128 |
| Number of potential DKA events (dapagliflozin) | 12 | Farxiga FDA Review (NDA/BLA 202293, 2021), p.111 |
| Application type | Efficacy Supplement | Farxiga FDA Review (NDA/BLA 202293, 2023), p.67 |
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.