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# Require More Infigratinib Info: Ascendis
- URL: https://www.fdaweb.com/require-more-infigratinib-info-ascendis/
- Published: 2026-10-08T19:28:00.000Z
- Updated: 2026-10-08T19:28:00.000Z
- Author: David McFarland
- Tags: Drugs

Ascendis Pharma is petitioning FDA to require additional information sufficient to evaluate unresolved safety questions before approving infigratinib to treat children with achondroplasia. The company’s 10/6 petition asks specifically that FDA:

- include internal neurodevelopmental experts on the review team to consider the risks infigratinib’s mechanism of action may pose to pediatric brain development;
- convene an advisory committee meeting with relevant neurodevelopment and FGFR (fibroblast growth factor receptors) central nervous system biology experts, members of the review division, and any other experts necessary to evaluate the benefit/risk profile of infigratinib when administered chronically; and
- require the applicant to submit additional nonclinical data demonstrating safety for the chronic use of infigratinib in pediatric patients, if FDA concludes that existing evidence does not resolve the concern about neurodevelopmental impact.

The document says the petition “raises a narrow but important safety question concerning the proposed chronic use of infigratinib in young children with achondroplasia.” It says the drug’s characteristics were considered as part of its prior development for an advanced oncology indication in adults, but there are distinct questions when the same molecule is proposed for chronic administration to children during periods of active brain development.

“The publicly available information concerning the infigratinib development program does not appear to resolve this specific safety concern,” it says. “Although the development program includes clinical studies evaluating efficacy and general safety, the currently available record does not appear to include nonclinical evidence specifically designed to evaluate the potential developmental consequences of chronic central nervous system exposure to a brain-penetrant FGFR inhibitor in young children. Nor does the available record appear to exclude the possibility of subtle developmental effects that may not be apparent through routine clinical safety monitoring or short-term observation.”