Basilea Announces the US FDA Approval of Cresemba (isavuconazole) in Pediatric Patients to Treat Invasive Aspergillosis & Invasive Mucormycosis
Shots:
- The US FDA approves the expanded use of Antifungal Cresemba in the US in Children with Invasive aspergillosis (IA) & invasive mucormycosis (IM)
- The approval was granted based on the outcomes of two pediatric clinical studies, incl. a P-II study evaluating the safety, effectiveness, & PK of Cresemba in pediatric patients aged 1 to 17 years, for the treatment of IA and IM
- Additionally, the US FDA granted Cresemba pediatric exclusivity, extending U.S. market exclusivity to Sept 2027. In Europe, a similar application awaits EMA assessment, with a decision expected in H1’24. Cresemba is approved in 76 countries and marketed in 71, incl. the US & most EU states
Ref: Basilea | Image: Basilea
Related News:- Astellas Reports the US FDA’s Acceptance of sNDA for Cresemba (isavuconazonium sulfate) to Treat Fungal Infections
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
