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Astellas Reports the US FDA’s Acceptance of sNDA for Cresemba (isavuconazonium sulfate) to Treat Fungal Infections

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Astellas

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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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