Indication · Base-Rate Reference
Neurology FDA Approval Rates
Historical first-cycle FDA approval rates for Neurology assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Neurology at FDA?
Historically high CRL rates outside rare neuro indications. Endpoint validity and effect size commonly challenged at AdCom. Recent Alzheimer's, ALS, and DMD approvals have raised questions about effect-size thresholds.
Neurology base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 75% | n~25 | standard 10 months | sometimes | Pediatric and symptomatic-to-modifying expansions; evidence bar remains high. |
| Breakthrough Therapy | 70% | n~20 | priority 6 months | usually | Breakthrough accelerates timelines but does not eliminate evidence debates. |
| NDA Priority | 65% | n~50 | priority 6 months | usually | ALS, rare pediatric, and Alzheimer's programs drive most priority filings; evidence debates common. |
| BLA | 60% | n~25 | standard 10 months | usually | Anti-amyloid and ASO programs; AdComs common for contested effect sizes. |
| Accelerated Approval | 55% | n~20 | priority 6 months | usually | Surrogate acceptance contentious (e.g., amyloid, SMN); AdComs frequent and often split. |
| Fast Track | 55% | n~40 | standard 10 months | usually | Designation frequent but approval outcomes still depend on effect size debates. |
| NDA Standard | 50% | n~70 | standard 10 months | usually | Endpoint validity and effect size commonly challenged; historically high CRL rate outside rare neuro indications. |
| Class 2 Resubmission | 50% | n~25 | 6 months from resubmission | usually | Efficacy-based CRLs often require new trials, reducing near-term resubmission success. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — use as framing, not prediction.
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