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news.Astellas has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of isavuconazole to treat invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.
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The company said that the NDA filing is a significant achievement for its Infectious Disease franchise and, if approved, isavuconazole will be another tool used to combat these infections.
Astellas executive vice president of Global Development and therapeutic area head of Infectious Diseases Bernie Zeiher 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," Zeiher said.
In February 2014, the FDA designated isavuconazole as a qualified infectious disease product (QIDP) for the treatment of invasive mucormycosis, while QIDP designation for invasive aspergillosis was granted in 2013.
Isavuconazole, an investigational once-daily intravenous and oral broad-spectrum antifungal being developed to treat severe invasive and life-threatening fungal infections, is the active moiety of the prodrug isavuconazonium sulfate.
In the Phase III invasive aspergillosis trial, isavuconazole showed non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42.
Image: Astellas seeks FDA approval for zygomycosis drug isavuconazole.Photo: courtesy of foto76/ freedigitalphotos.net