Astellas today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.
"This NDA submission is a significant achievement for Astellas' Infectious Disease franchise and, if approved, isavuconazole will be another tool physicians will be able to use to combat these serious infections," said Bernie Zeiher, executive vice president, Global Development and therapeutic area head of Infectious Diseases at Astellas. "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."
In February, the FDA designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for invasive mucormycosis. QIDP designation for the treatment of invasive aspergillosis was granted last year. QIDP status provides priority review and a five-year extension of market exclusivity in the United States. These incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act. Also, in 2013, isavuconazole was granted orphan drug status for invasive aspergillosis and invasive mucormycosis.