Indication · Base-Rate Reference
Other FDA Approval Rates
Historical first-cycle FDA approval rates for Other assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Other at FDA?
Catch-all for therapeutic areas not specified above (ophthalmology, dermatology, hematology, etc). Base rates vary widely — use this as a rough benchmark only.
Other base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 82% | n~150 | standard 10 months | rarely | Aggregated across therapeutic areas; sBLA success rates consistently outpace original BLAs. |
| Breakthrough Therapy | 82% | n~60 | priority 6 months | rarely | Breakthrough designation is among the strongest predictors of approval. |
| NDA Priority | 72% | n~120 | priority 6 months | sometimes | Aggregated across dermatology, ophthalmology, renal, and GI; priority usage uneven across TAs. |
| BLA | 70% | n~80 | standard 10 months | sometimes | Includes ophthalmology and dermatology biologics; outcomes generally favorable. |
| Accelerated Approval | 70% | n~50 | priority 6 months | sometimes | FDA increasingly requires confirmatory trials enrolling at approval. |
| Fast Track | 68% | n~150 | standard 10 months | sometimes | Fast Track alone is a weaker approval predictor than Breakthrough or Priority. |
| Class 2 Resubmission | 65% | n~80 | 6 months from resubmission | sometimes | Aggregated across TAs; generally ~60-70% approved on first resubmission. |
| NDA Standard | 60% | n~200 | standard 10 months | sometimes | Aggregated across derm, ophthalmology, GI, GU, and renal; heterogeneous outcomes. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — use as framing, not prediction.
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