Will the FDA approve the paediatric extension of cefiderocol before 30 April 2027?
deadline 2027-04-30
confidence medium
tier 1 evidence
52%Asturna estimate
Resolution criterion
Yes if the FDA approves the paediatric sNDA by 30 April 2027 (Drugs@FDA or a Shionogi release). A complete response letter, a postponed PDUFA date, or no decision by that date all count as no. An approval covering only one of the two indications (hospital-acquired pneumonia or complicated urinary tract infections) counts as no for this question; flag for manual review.
Verified starting state
sNDA accepted, PDUFA date 23 February 2027, for hospital-acquired pneumonia and complicated urinary tract infections in children from 26 weeks gestational age, based on three studies totalling 154 children. The paediatric extrapolation rests on a small sample. (17 July 2026)
What pushes it up
- The FDA has accepted the sNDA with a PDUFA date of 23 February 2027, which falls two months before the resolution deadline [Starting State, Tier 1].
- Cefiderocol is a critical antibiotic for drug-resistant Gram-negative infections, and its strategic importance is highlighted by BARDA procurement contracts [2, Tier 4].
- The drug is already approved for adults, meaning the safety profile of the molecule itself is well-characterized [Starting State, Tier 1].
What pushes it down
- The paediatric extrapolation is based on a relatively small sample of 154 children, which increases the risk of the FDA requiring additional data or issuing a Complete Response Letter [Starting State, Tier 1].
- The resolution criterion is strict: approval must cover both HAP and cUTI indications; a partial approval counts as a 'No' [Resolution Criterion].
- Any major amendment to the filing would likely trigger a standard 3-month PDUFA extension to 23 May 2027, which would cause the application to miss the 30 April deadline [Starting State, Tier 1].
What would move this number most
The primary uncertainty is whether the FDA will find the 154-patient dataset sufficient to support both indications simultaneously without requesting further data or a major amendment that would delay the decision beyond the deadline.
How this number is built
| Deadline | 2027-04-30 |
| Base rate | 40% |
| Best evidence | tier 1 · 3 article(s) used |
| Independent runs | 48 · 55 (spread 7 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-07 09:10 |
| Model | gemini-3-flash-preview |
Sources consulted
Probability history
2026-10-07 09:10 52% 8 article(s) on file · gemini-3-flash-preview
- What pushes it up. The FDA has accepted the sNDA with a PDUFA date of 23 February 2027, which falls two months before the resolution deadline [Starting State, Tier 1].
- What pushes it up. Cefiderocol is a critical antibiotic for drug-resistant Gram-negative infections, and its strategic importance is highlighted by BARDA procurement contracts [2, Tier 4].
- What pushes it up. The drug is already approved for adults, meaning the safety profile of the molecule itself is well-characterized [Starting State, Tier 1].
- What pushes it down. The paediatric extrapolation is based on a relatively small sample of 154 children, which increases the risk of the FDA requiring additional data or issuing a Complete Response Letter [Starting State, Tier 1].
- What pushes it down. The resolution criterion is strict: approval must cover both HAP and cUTI indications; a partial approval counts as a 'No' [Resolution Criterion].
- What pushes it down. Any major amendment to the filing would likely trigger a standard 3-month PDUFA extension to 23 May 2027, which would cause the application to miss the 30 April deadline [Starting State, Tier 1].
- What would move this number most. The primary uncertainty is whether the FDA will find the 154-patient dataset sufficient to support both indications simultaneously without requesting further data or a major amendment that would delay the decision beyond the deadline.
2026-09-21 22:26 48% 5 article(s) on file · openai/gpt-oss-120b (Groq)
Reasons not recorded for this revision (detailed history has only been kept since recently).
2026-09-19 13:46 80% 5 article(s) on file · gemini-3.5-flash
Reasons not recorded for this revision (detailed history has only been kept since recently).