FDAsafety guidance66% confidence
FDA AP — NDA219627
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application NDA219627. Sponsor: BAYER HEALTHCARE PHARMS. Submission status: AP. Submission type: ORIG. Review priority: STANDARD.
Supporting Context
- Therapeutic area
- Neurology · Autoimmune Disorders
- Sub-indication
- Immunology
Related signal: FDA Accepts Supplement Application for ENSPRYNG (Satralizumab)