FDA grants approval for Astellas’ antifungal therapy Cresemba

The US Food and Drug Administration (FDA) has granted approval for Astellas Pharma’s azole antifungal drug Cresemba (isavuconazonium sulfate) to treat children with invasive aspergillosis (IA) and invasive mucormycosis (IM).

The regulator accepted the company’s supplemental New Drug Application (sNDA) for Cresemba to treat these fungal infections in children in August 2023.

Cresemba by injection is indicated for children aged one year and above and is the only azole antifungal drug for IA and IM treatment in this age group.

Cresemba capsules are indicated for those aged six years and older, weighing at least 16 kg.

The approval is based on data from two paediatric clinical studies, including a Phase II trial in subjects aged one to 17 years.

The multicentre, non-comparative, open-label Phase II trial analysed the drug’s efficacy, safety and pharmacokinetics in 31 paediatric patients. 

At day 42 and day 84, all-cause case fatality was 6.5% and 9.7% respectively. These outcomes were not linked to the antifungal drug.

Treatment offered response rates of 54.8% while treatment-emergent adverse events (TEAEs) were observed in 93.5% of subjects.

29% of subjects reported TEAEs associated with the antifungal drug.

The treatment initially received approval from the FDA to treat adult IA and IM patients in 2015.

Astellas Pharma US Medical Specialties Business Unit head and senior vice-president Lynn Fenicchia stated: “The recent Covid-19 pandemic drove an uptick in these serious and life-threatening fungal infections, presenting an even greater urgency to address this growing unmet medical need.

“Patients are waiting, and we know that young IA and IM patients are most at risk. The approval will bring hope to this highly vulnerable patient population with limited treatment options.”

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