ASTRAZENECA AB — Farxiga FDA Review (NDA/BLA 202293, 2023)
AstraZeneca PLC · 2023 · FDA Review (Drugs@FDA) · company profile →
Report summary
FARXIGA (dapagliflozin) received FDA approval on May 8, 2023, for multiple indications, including reducing cardiovascular death and heart failure hospitalization, and improving glycemic control in type 2 diabetes. Clinical trials demonstrated its efficacy in reducing HbA1c, FPG, and body weight, and showed significant benefits in cardiovascular outcomes (DECLARE, DAPA-HF, DELIVER) and chronic kidney disease (DAPA-CKD). The DELIVER trial specifically highlighted a significant reduction in cardiovascular death or heart failure events in patients with heart failure (HR 0.82, p<0.001). Safety findings indicate common adverse reactions like volume depletion, genital mycotic infections, and hypoglycemia, with no new risks identified in the DELIVER trial. The drug's safety profile is consistent with other SGLT2 inhibitors, with detailed information on potential serious side effects provided in the Medication Guide.
Key findings — cited to the page
| Mean change in KCCQ-TSS from baseline at 8 months | 8.3 | DELIVER · Global · p.113 |
| KCCQ-TSS p-value | 0.009 | DELIVER · Global · p.113 |
| DELIVER trial population LVEF | >40 % | DELIVER (D169CC00001) · Global · p.89 |
| CV Death p-value (LVEF <60%) | 0.61 | DELIVER · Global · p.112 |
| KCCQ-TSS win ratio | 1.11 | DELIVER · Global · p.113 |
| KCCQ-TSS win ratio 95% CI | 1.03, 1.21 | DELIVER · Global · p.113 |
| Application type | Efficacy Supplement | FARXIGA · p.67 |
| sNDA number | 202293 S26 | FARXIGA (Dapagliflozin) · p.87 |
| DELIVER trial dapagliflozin dose | 10 mg | DELIVER (D169CC00001) · Global · p.89 |
| DELIVER trial dapagliflozin treated N | 3126 | DELIVER (D169CC00001) · Global · p.89 |
| Mean change in KCCQ-TSS from baseline at 8 months (placebo) | 5.2 | DELIVER · Global · p.113 |
| All-cause mortality Hazard Ratio | 0.94 | DELIVER · Global · p.113 |
Source: AstraZeneca PLC ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →