Astellas Reports the US FDA’s Acceptance of sNDA for Cresemba (isavuconazonium sulfate) to Treat Fungal Infections
Shots:
- The US FDA has accepted the sNDA of Cresemba (isavuconazonium sulfate), an azole antifungal seeking approval for invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients aged 1-17yrs. The US FDA’s decision is expected in Dec 2023
- The sNDA was based on the P-II study results evaluating the safety, efficacy, and PK of Cresemba in 31 pediatric patients aged 1-17yrs. Patients received a loading dose of isavuconazonium sulfate via IV or oral administration at the investigator’s discretion q8h (± 2hrs.) on days 1 & 2, followed by qd maintenance dosing while primary efficacy EPs was all-cause mortality through day 42.
- If Cresemba is approved, it will offer a new treatment option for pediatric patients for invasive fungal inf.
Ref: PR Newswire | Image: Astellas
Related News:- Basilea and Pfizer Collaborated to Commercialize Cresemba for Invasive Aspergillosis and Mucormycosis
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