Astellas Pharma US, Inc. has obtained approval from the U.S. Food and Drug Administration (FDA) for the use of CRESEMBA® (isavuconazonium sulfate), an azole antifungal drug, in treating invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. This endorsement includes CRESEMBA for injection for patients aged 1 year and older and CRESEMBA capsules for patients aged 6 years and older, weighing 16 kilograms (kg) and above. CRESEMBA is now the only azole antifungal therapy authorized for managing IA and IM in patients as young as one.

Dr. Antonio C. Arrieta, Medical Director of Pediatric Infectious Disease at Children's Health of Orange County, expressed concern about invasive fungal infections in pediatric, adolescent, and young adult patients with hematologic malignancies, transplant recipients, and primary immune deficiencies. He highlighted the significance of the FDA's approval of CRESEMBA for pediatric patients, providing a necessary treatment option for infections linked to high morbidity and fatality rates.

Lynn Fenicchia, Senior Vice President and Head of US Medical Specialties Business Unit at Astellas, emphasized the urgency of addressing the growing unmet medical need, particularly considering the increased prevalence of these serious fungal infections during the recent COVID-19 pandemic. Fenicchia expressed confidence that the approval would bring hope to a highly vulnerable patient population with limited treatment options.

The FDA approval is based on findings from two pediatric clinical studies, including a Phase 2 multicenter study assessing the safety, efficacy, and pharmacokinetics of CRESEMBA in pediatric patients aged 1 to 17 years old with IA or IM. The study involved the treatment of 31 patients with CRESEMBA (10 mg/kg) every 8 hours on days 1 and 2, followed by once-daily administration for ≤84 days for IA or ≤180 days for IM. The median treatment duration was 55 days, with a successful response rate of 54.8% at the end of treatment. Treatment emergent adverse events occurred in 93.5% of patients, with 29.0% experiencing drug-related adverse events. The FDA also granted pediatric exclusivity for CRESEMBA, extending its market exclusivity in the United States by an additional six months.

Invasive aspergillosis and invasive mucormycosis are life-threatening fungal infections primarily observed in immunocompromised patients, such as those with leukemia. These infections are a significant cause of morbidity and mortality in immunocompromised and hospitalized pediatric patients.

CRESEMBA (isavuconazonium sulfate) is now approved for the treatment of invasive aspergillosis and invasive mucormycosis in both adults and pediatric patients, providing a critical treatment option for a broader range of individuals facing these serious fungal infections.

 

Source: prnewswire.com

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