Isavuconazonium Sulfate Under Review for Invasive Fungal Infections in Pediatric Patients

The Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for isavuconazonium sulfate, an azole antifungal, for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients 1 to 17 years of age. Isavuconazonium sulfate is currently marketed under the brand name Cresemba^® and is approved for the treatment of IA or IM in adults.

The application for pediatric use is supported by data from an open-label, noncomparative, phase 2 study (ClinicalTrials.gov Identifier: NCT03816176) that evaluated the efficacy and safety of isavuconazonium sulfate for the treatment of IA or IM in 31 patients aged 1 to 17 years. Study participants received a loading dose of isavuconazonium sulfate via intravenous or oral administration at the investigator’s discretion every 8 hours (± 2 hours) on days 1 and 2 followed by once-daily maintenance dosing. The primary efficacy endpoint was all-cause mortality through day 42. 

Detailed study results will be presented at a future medical meeting. A Prescription Drug User Fee Act target date of December 9, 2023 has been set for the application.

“Since its approval over 8 years ago, Cresemba has been helping adult patients and their physicians fight certain life-threatening fungal infections when they are often critically ill with other diseases,” said Lynn Fenicchia, senior vice president and Head of US Medical Specialties Business Unit, Astellas. “This sNDA acceptance by the FDA brings Astellas one step closer to helping pediatric patients by potentially having a new treatment option available for IA and IM for a younger patient population, if approved.”