ASTRAZENECA AB — Farxiga FDA Review (NDA/BLA 202293, 2021)
AstraZeneca PLC · 2021 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved AstraZeneca's FARXIGA (dapagliflozin) on May 5, 2020, for a new indication: reducing cardiovascular death and heart failure hospitalization in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. This approval, based primarily on the DAPA-HF trial, demonstrated FARXIGA's efficacy in improving cardiovascular outcomes and heart failure symptoms (KCCQ-TSS), though the clinical meaningfulness of KCCQ changes was debated. Safety data from DAPA-HF and other trials showed a generally favorable profile, with known risks including volume depletion, genital mycotic infections, and diabetic ketoacidosis. The report details dosage, contraindications, warnings, and adverse reactions, alongside pharmacokinetic data and drug interactions. FARXIGA's efficacy in various type 2 diabetes combination therapies and its impact on MACE were also reviewed. The document also covers product information, storage, and patient counseling.
Key findings — cited to the page
| Hazard ratio for CV death | 0.98 | DECLARE · p.44 |
| Package Size | 30 Bottles | FARXIGA · p.52 |
| MACE events per 100 patient-years | 2.46 | DECLARE · p.44 |
| Hazard ratio for hospitalization for heart failure | 0.73 | DECLARE · p.44 |
| Hazard ratio for composite of CV Death or Hospitalization for Heart Failure | 0.75 | DAPA-HF · p.46 |
| Tablet Strength | 5 mg | FARXIGA · p.52 |
| Application Type/Number | NDA 202293 | FARXIGA (dapagliflozin) · p.164 |
| Body Weight change from baseline (adjusted mean) | -0.1 | · p.41 |
| Hazard ratio of MACE | 0.93 | DECLARE · p.44 |
| Hazard ratio for composite of hospitalization for heart failure or CV death | 0.83 | DECLARE · p.44 |
| Supplement Number | S-020 | FARXIGA (dapagliflozin) · p.164 |
| NDC Code | 0310-6205-30 | FARXIGA · p.52 |
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 →