Astellas Fungal Treatment Gets QIDP Status

Astellas Pharma US, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc., has received Qualified Infectious Disease Product (QIDP) designation from the FDA for isavuconazole as a 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 U.S.. 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 possible 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.