FDA approves expanded use of Astella's Cresemba

Astellas Pharma has received the Food and Drug Administration’s permission for Cresemba (isavuconazonium sulfate), an azole antifungal drug, for the treatment of invasive aspergillosis and invasive mucormycosis in pediatric patients. 

Cresemba for injection is approved for adults and now for pediatric patients 1 year of age and older. Cresemba capsules are approved for adults and now for pediatric patients 6 years of age and older who weigh 16 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.

"Invasive fungal infections are a significant concern to healthcare professionals who care for pediatric, adolescents and young adults with hematologic malignancies, transplant recipients and primary immune deficiencies," said Antonio Arrieta, medical director of Pediatric 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 pediatric patients adds a much-needed treatment option."

[Read more: Pfizer, Astellas obtain FDA OK for Xtandi]

"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 U.S. Medical Specialties Business Unit at 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."