FDAsafety guidance83% confidence
FDA AP — BAXFENDY (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Anthos Therapeutics.
Regulatory Analysis
Application NDA219878. Sponsor: ASTRAZENECA AB. Submission status: AP. Submission type: ORIG. Review priority: PRIORITY. Active ingredients: BAXDROSTAT.
Supporting Context
- Therapeutic area
- Cardiology · Atrial Fibrillation
- Sub-indication
- Hypertension
Related signal: Anthos and Novartis initiate LILAC-TIMI 76 trial for abelacimab in high-risk AF patients