FDAsafety guidance84% confidence
July - September 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Xeljanz; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
July - September 2022 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Supporting Context
- Therapeutic area
- Immunology · JAK Inhibitors
- Sub-indication
- General
Related signal: FDA Updates Boxed Warnings for JAK Inhibitors Due to Serious Risks