Astellas Pharma US, Inc., a subsidiary of Astellas Pharma Inc. based in Tokyo, Japan, announced today that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive aspergillosis. QIDP status provides priority review and a five-year extension of market exclusivity if a product receiving such a designation is approved in the United States. These incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act.
The possibility of a five-year extension is in addition to the potential seven-year exclusivity based on isavuconazole's FDA orphan drug designation for the treatment of invasive aspergillosis. In the U.S., isavuconazole also received orphan drug designation for the treatment of zygomycosis, a life-threatening invasive fungal infection (IFI) caused by emerging molds.
"Invasive aspergillosis and zygomycosis are life threatening infections that typically occur in severely immunocompromised patients. Acceptance of Aspergillus as a qualified pathogen is a recognition of the need for new treatment options for patients infected with these fungi," said Bernie Zeiher, Senior Vice President and Global Therapeutic Area Head of Immunology and Infectious Diseases at Astellas Pharma Global Development, Inc. "We applaud the bipartisan Congressional supporters of the GAIN Act for their commitment to encouraging investment in treatments for these serious infectious diseases through the passage of this legislation."
IFIs are debilitating or life-threatening infections that attack internal tissues or organs and can spread through the bloodstream. Fungi commonly involved in IFIs include Aspergillus (molds) and Candida (yeasts).,  Invasive aspergillosis is caused by Aspergillus molds and typically affects patients with an impaired or weakened immune system. It is estimated to occur in five to 13 percent of recipients of bone marrow transplants often associated with leukemia, five to 25 percent of patients who have received heart or lung transplants, and 10 to 20 percent of patients who are receiving intensive chemotherapy for leukemia. Mortality rates for transplant patients with invasive aspergillosis have been reported to be between 34 and 58 percent. Zygomycosis is an important emerging fungal infection, associated with high morbidity and mortality. Mortality rates have been reported to be as high as 80 percent in infected transplant patients.