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# Astellas sNDA Filed for Pediatric Cresemba
- URL: https://www.fdaweb.com/astellas-snda-filed-for-pediatric-cresemba/
- Published: 2023-08-11T12:00:00.000Z
- Updated: 2026-09-14T18:50:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155081

FDA has accepted for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal for treating invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients aged one to 17 years old. The submission is based on data from a Phase 2 open-label, multicenter study ([NCT03816176](https://c212.net/c/link/?t=0&l=en&o=3940836-1&h=1051302959&u=https%3A%2F%2Fclassic.clinicaltrials.gov%2Fct2%2Fshow%2FNCT03816176&a=NCT03816176&ref=fdaweb.com)). The agency has set a user fee review action target date of 12/9.

Cresemba is currently approved for treating IA and IM in adults. The company says IA and IM are a major cause of morbidity and death among immunocompromised and hospitalized pediatric patients.