Indication · Base-Rate Reference
Immunology FDA Approval Rates
Historical first-cycle FDA approval rates for Immunology assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Immunology at FDA?
Crowded category with multiple approved biologics in most major indications. CRLs often reflect differentiation or long-term safety concerns rather than efficacy.
Immunology base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 88% | n~120 | standard 10 months | rarely | Class-effect extrapolation supports high approval rates for new indications. |
| Breakthrough Therapy | 85% | n~25 | priority 6 months | rarely | Usually approved first cycle with expedited label negotiations. |
| BLA | 78% | n~80 | standard 10 months | rarely | Mature class with well-understood endpoints; CRLs tend to be CMC or facility-related. |
| NDA Priority | 75% | n~40 | priority 6 months | sometimes | Priority often tied to serious autoimmune indications; approvals usually first cycle. |
| Fast Track | 72% | n~40 | standard 10 months | sometimes | Used for serious autoimmune indications; generally favorable approval rates. |
| Class 2 Resubmission | 70% | n~25 | 6 months from resubmission | sometimes | Most resubmissions resolve manufacturing or labeling issues and are approved. |
| Accelerated Approval | 70% | n~15 | priority 6 months | sometimes | Rare autoimmune programs; acceptable biomarkers support most approvals. |
| NDA Standard | 65% | n~80 | standard 10 months | sometimes | Well-characterized endpoints support approval; safety labeling tends to be the main negotiation. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — use as framing, not prediction.
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