Indication · Base-Rate Reference
Endocrinology/Metabolic FDA Approval Rates
Historical first-cycle FDA approval rates for Endocrinology/Metabolic assets across 8 regulatory pathways — NDA Standard, NDA Priority, BLA, sBLA, Class 2 Resubmission, Accelerated Approval, Breakthrough Therapy, Fast Track.
What's specific about Endocrinology/Metabolic at FDA?
Obesity and diabetes have become the highest-volume metabolic categories post-GLP-1 class. Cardiometabolic endpoints are heavily scrutinized.
Endocrinology/Metabolic base rates by pathway
| Pathway | First-cycle approval | Sample size | Typical clock | AdCom | Notes |
|---|---|---|---|---|---|
| sBLA | 82% | n~40 | standard 10 months | rarely | Weight management and CV risk expansions for GLP-1 class; strong first-cycle record. |
| Breakthrough Therapy | 80% | n~15 | priority 6 months | sometimes | Rare metabolic and novel mechanism programs; strong first-cycle record. |
| NDA Priority | 70% | n~30 | priority 6 months | sometimes | Rare metabolic diseases dominate priority; classic diabetes programs less often get priority. |
| BLA | 70% | n~30 | standard 10 months | sometimes | GLP-1s and similar biologics; safety labeling and CV risk are usual review themes. |
| Fast Track | 65% | n~25 | standard 10 months | sometimes | Rare metabolic and NASH programs most common; long-term safety remains the review hurdle. |
| NDA Standard | 60% | n~70 | standard 10 months | sometimes | CV outcomes trials often required post-approval; CRLs frequently cite long-term safety. |
| Class 2 Resubmission | 60% | n~20 | 6 months from resubmission | sometimes | CV safety CRLs can require new outcomes data. |
| Accelerated Approval | 60% | n~15 | priority 6 months | usually | MASH/NASH and rare metabolic programs; surrogate-to-outcome translation closely scrutinized. |
Base rates drawn from published FDA approval analyses covering roughly 2008-2022. Approximate — use as framing, not prediction.
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