FDA grants orphan and paediatric exclusivities for Cresemba


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

In December 2023, Cresemba for injection was approved for paediatric patients one year of age and older and capsules for paediatric patients six years of age and older who weigh 16kg and greater.

As the first company to obtain FDA approval for the treatment of IA and IM in patients as young as one for a triazole antifungal, Astellas has received orphan drug exclusivity, which provides seven years of exclusive marketing rights for Cresemba in those indications. Paediatric exclusivity extends that period by another six months.

Laura Kovanda, Executive Director, Asset Lead, BioPharma Development, Astellas, said: “Astellas recognises the importance of addressing significant unmet medical needs, especially for paediatric patients with rare and potentially life-threatening IA and IM infections. I am incredibly proud of the Astellas team for advancing research, development and commercialisation to offer Cresemba to paediatric patients who have limited treatment options.”

Fungal infections IA and IM are a major cause of morbidity and death among immunocompromised and hospitalised paediatric patients. Cresemba is the only azole antifungal therapy FDA approved for the treatment of IA and IM in patients as young as one.

Diana Spencer, Senior Digital Content Editor, DDW

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