Astellas Receives FDA Approval for Cresemba

Astellas has announced that the FDA has approved its New Drug Application (NDA) for the use of Cresemba (isavuconazonium sulfate), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). These are life-threatening fungal infections predominantly occurring in immunocompromised patients.

“We’re pleased with the FDA’s approval of Cresemba for use in treating patients with these life-threatening infections,” said Bernie Zeiher, executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. “We are proud to be able to offer a new treatment for patients in an area for which there is a significant unmet medical need.”

“It is extremely gratifying to have been a part of the clinical trials of Cresemba since inception, knowing patients and their physicians will now have this option,” said Thomas F. Patterson, Division of Infectious Diseases chief at The University of Texas Health Science Center at San Antonio and director of the San Antonio Center for Medical Mycology. “Cresemba is an important new therapy for physicians treating patients with invasive aspergillosis and invasive mucormycosis fungal infections.”

The Cresemba NDA was submitted by Astellas on 8 July 2014. Cresemba is being co-developed with Basilea Pharmaceutica International Ltd. Basilea submitted a European Marketing Authorization Application on July 16, 2014 for the treatment of invasive aspergillosis and mucormycosis in adults.

Upon this approval, Astellas will pay a CHF 30 million milestone payment to Basilea Pharmaceutica International Ltd. under their license and co-development agreement.