FDA accepts Astellas’ sNDA for Cresemba in children

Betsy Goodfellow | August 11, 2023 | News story | Research and Development Astella, FDA, Paediatrics, cresemba 

The US Food and Drug Administration (FDA) announced it has accepted Astellas Pharma’s supplemental New Drug Application (sNDA) for Cresemba on 10 August 2023. The drug was previously approved for adults but is now available for children aged one to 17, for the intended use of treating invasive aspergillosis (IA) and invasive mucormycosis (IM); these are conditions that are known to cause death in infants.

Tadaaki Taniguch, chief medical officer at Astellas, commented: “While rare in the general populationIA or IM can be incredibly dangerous for immunocompromised children, including those faced with blood and other cancers, and there are very limited treatment options. The collective efforts by our research and development teams, which have led to the successful sNDA acceptance for Cresemba by the FDA, reflect our ongoing commitment to addressing vulnerable populations with high unmet medical needs.”

The application follows the results of a phase 2 multicenter study which evaluated Cresemba’s safety and efficacy when used with paediatric patients. The FDA is hoping to release the drug on 9 December 2023.

Lynn Fenicchia, senior vice president at Astellas, stated: “Since its approval over eight 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. This sNDA acceptance by the FDA brings Astellas one step closer to helping paediatric patients by potentially having a new treatment option available for IA and IM for a younger patient population, if approved.”

Rebecca Lee

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