AstraZeneca PLC — Farxiga FDA Review (NDA202293, SUPPL 24, 2021)
AstraZeneca PLC · 2021 · FDA Review (openFDA) · company profile →
Report summary
AstraZeneca's Farxiga (dapagliflozin) demonstrated substantial efficacy in reducing the risk of sustained eGFR decline, ESKD, CV death, and hospitalization for heart failure in adults with CKD at risk of progression. The DAPA-CKD trial, a randomized, double-blind study of 4,304 patients, showed significant benefits for primary (HR 0.61, p < 0.0001) and secondary endpoints, leading to early termination due to overwhelming efficacy. The DECLARE trial, while not meeting its primary MACE endpoint in T2DM patients, provided supportive evidence with a significant reduction in a renal composite endpoint. The safety profile in DAPA-CKD was consistent with previous findings, with no new safety concerns identified, even in patients with lower eGFR.
Key findings — cited to the page
| Alpha level for type 1 error control (one-sided) | 0.025 | · p.41 |
| Alpha level for type 1 error control (two-sided) | 0.05 | · p.41 |
| eGFR decline for primary endpoint | ≥50 % | · p.37 |
| HbA1c threshold for new T2DM diagnosis | ≥6.5 % | · p.37 |
| Patients with placebo exposure after dialysis | 47 patients | · p.36 |
| Patients with dapagliflozin exposure after dialysis | 29 patients | · p.36 |
| Sulfonylurea dose reduction recommendation for T2DM patients | 25-50 % | · p.35 |
| eGFR decline for AKI definition | doubling of serum creatinine | · p.37 |
| HbA1c reduction recommendation for T2DM patients | 10-20 % | · p.35 |
| eGFR threshold for ESKD definition | <15 mL/min/1.73m2 | · p.37 |
| HbA1c threshold for dose reduction recommendation | ≤7 % | · p.35 |
| Primary endpoint event accrual for sample size calculation | 681 events | · p.44 |
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 →