Astellas submits NDA for isavuconazole to treat deadly fungal infections

Japanese drug major Astellas Pharma (TYO: 4503) has submitted a New Drug Application to the US Food and Drug Administration, seeking approval for its drug isavuconazole.

Isavuconazole has been developed for the treatment of invasive aspergillosis and invasive mucormcosis (also known as zygomycosis), which are life-threatening fungal infections that generally occur in immunocompromised patients. Last year Astellas announced positive topline data from the Phase III invasive aspergillosis study (SECURE) into isavuconazole, being co-developed with Swiss company Basilea Pharmaceutica (SIX: BSLN).

Bernie Zeiher, executive vice president, global development and therapeutic area head of infectious diseases at Astellas, said:  "There is a growing need for new antifungal therapies like isavuconazole. Serious fungal infections are on the rise due to the increasing numbers of immunosuppressed patients such as those undergoing high-dose chemotherapy and/or hematopoietic stem-cell transplantation for leukemia.”