FDAsafety guidance72% confidence
FDA AP — SAPHNELO (ORIG)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to AstraZeneca.
Regulatory Analysis
Application BLA761451. Sponsor: ASTRAZENECA AB. Submission status: AP. Submission type: ORIG. Review priority: STANDARD. Active ingredients: ANIFROLUMAB-FNIA.
Supporting Context
- Therapeutic area
- Immunology · Systemic Lupus Erythematosus
- Sub-indication
- General
Related signal: AstraZeneca's Anifrolumab Study for Systemic Lupus Erythematosus Underway