Indication · Base-Rate Reference
Cardiovascular FDA Approval Rates
Historical first-cycle FDA approval rates for Cardiovascular assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Cardiovascular at FDA?
Large cardiovascular outcomes trials (CVOTs) are typically required. Mortality endpoints are powered conservatively; CRLs frequently cite CV safety or underpowered mortality benefit.
Cardiovascular base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 80% | n~30 | standard 10 months | sometimes | Expansion to new outcomes claims (MACE, HF); AdComs possible when new populations are controversial. |
| Breakthrough Therapy | 75% | n~15 | priority 6 months | sometimes | Breakthrough rare in CV; when granted, usually leads to first-cycle approval. |
| NDA Priority | 70% | n~40 | priority 6 months | usually | Priority designations rarer; approvals tend to require robust outcomes data. |
| BLA | 65% | n~20 | standard 10 months | usually | PCSK9 class and similar; outcomes data and immunogenicity are key review focal points. |
| Accelerated Approval | 60% | n~10 | priority 6 months | usually | Rarely used; surrogate-to-outcome validation typically required. |
| Fast Track | 60% | n~30 | standard 10 months | usually | Fast Track improves communication cadence but outcomes-trial requirements persist. |
| NDA Standard | 55% | n~60 | standard 10 months | usually | Large outcomes trials required; CRLs frequently cite CV safety or underpowered mortality benefit. |
| Class 2 Resubmission | 55% | n~20 | 6 months from resubmission | usually | Mortality/safety CRLs hardest to overcome without new trial data. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — use as framing, not prediction.
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