FDAsafety guidance77% confidence
FDA AP — BAXFENDY (ORIG)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (asthma) as AstraZeneca; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA219878. Sponsor: ASTRAZENECA AB. Submission status: AP. Submission type: ORIG. Review priority: PRIORITY. Active ingredients: BAXDROSTAT.
Supporting Context
- Therapeutic area
- Respiratory · Asthma
- Sub-indication
- Asthma
Related signal: FDA Accepts Supplemental Application for Fasenra (Benralizumab) by AstraZeneca