FDA orphan and pediatric exclusivity for Astellas’ antifungal drug

12 March 2024

The US Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients.

Cresemba is marketed in the USA by Japanese drug major Astellas Pharma (TYO: 4503) under license from Swiss drugmaker Basilea Pharmaceutica (SIX: BSLN).

On December 8, 2023, Cresemba for injection was approved for pediatric patients one year of age and older and capsules for pediatric patients six years and older who weigh 16 kilograms (kg) and greater. The consensus from GlobalData forecasts predict that Cresemba will generate $450 million in 2023.

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