ASTRAZENECA AB — Farxiga FDA Review (NDA/BLA 202293, 2021)
AstraZeneca PLC · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package, dated October 18, 2019, details the approval of Farxiga (dapagliflozin) and Xigduo XR for glycemic control and reducing hospitalization risk for heart failure in adults with type 2 diabetes. The approval is based on the DECLARE cardiovascular outcomes trial, which demonstrated Farxiga's non-inferiority for MACE and superiority in reducing heart failure hospitalization or CV death. The report summarizes extensive efficacy data from various monotherapy and combination studies, showing significant improvements in HbA1c, FPG, and body weight. Safety findings cover volume depletion, hypoglycemia, genital mycotic infections, ketoacidosis, and changes in laboratory parameters. The DECLARE trial, a large, multicenter study, enrolled over 17,000 patients, confirming CV safety and providing detailed safety profiles, including specific adverse events and post-marketing surveillance. The document also outlines regulatory history, trial design, and proposed label changes.
Key findings — cited to the page
| Constipation incidence (FARXIGA 5 mg) | 2.2 % | FARXIGA · p.16 |
| Constipation incidence (FARXIGA 10 mg) | 1.9 % | FARXIGA · p.16 |
| Discomfort with urination incidence (Placebo) | 0.7 % | FARXIGA · p.16 |
| Discomfort with urination incidence (FARXIGA 5 mg) | 1.6 % | FARXIGA · p.16 |
| Discomfort with urination incidence (FARXIGA 10 mg) | 2.1 % | FARXIGA · p.16 |
| Pain in extremity incidence (Placebo) | 1.4 % | FARXIGA · p.16 |
| Pain in extremity incidence (FARXIGA 5 mg) | 2.0 % | FARXIGA · p.16 |
| Pain in extremity incidence (FARXIGA 10 mg) | 1.7 % | FARXIGA · p.16 |
| FPG reduction | -44.72 mg/dL | NCT02229396 · p.41 |
| FPG reduction | -40.53 mg/dL | NCT02229396 · p.41 |
| Urgent HF visits in placebo arm (N) | 8 | DECLARE · p.151 |
| Constipation incidence (Placebo) | 1.5 % | FARXIGA · p.16 |
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 →