Astellas Pharma Bags US FDA Nod For Cresemba To Treat Invasive Aspergillosis

As per Astellas Pharma US, Inc. Cresemba (isavuconazonium sulfate), an azole antifungal medication, has been approved by the US Food and medication Administration (FDA) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in paediatric patients.

Cresemba for injection is approved for adults and now for paediatric patients 1 year of age and older. Cresemba capsules are approved for adults and now for paediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater. With this approval, Cresemba is now the only azole antifungal therapy approved for the treatment of IA and IM in patients as young as one, as per Pharmabiz.

"Invasive fungal infections are a significant concern to healthcare professionals who care for paediatric, adolescents and young adults with hematologic malignancies, transplant recipients and primary immune deficiencies," said Antonio C. Arrieta, M.D., medical director, Paediatric Infectious Disease, Children's Health of Orange County. "IA, currently the most common invasive mold infection in these patients, and IM are associated with significant morbidity and high fatality rates. The FDA approval of Cresemba for paediatric patients adds a much-needed treatment option."

"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," said Lynn Fenicchia, senior vice president and Head of US Medical Specialties Business Unit, Astellas. "Patients are waiting, and we know that young IA and IM patients are most at risk. Today's approval will bring hope to this highly vulnerable patient population with limited treatment options."

The approval is based on results from two paediatric clinical studies, including a phase 2 open-label, non-comparative, multicenter study (NCT03816176) evaluating the safety, efficacy and pharmacokinetics of Cresemba for the treatment of IA or IM in paediatric patients aged 1 to 17 years old.  

The approval is based on the findings of two paediatric clinical studies, including a phase 2 open-label, non-comparative, multicenter research (NCT03816176) examining Cresemba's safety, effectiveness, and pharmacokinetics in paediatric patients aged 1 to 17 years old.