Astellas Pharma Global Development, Inc., a subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503), 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 mucormycosis (also known as zygomycosis), a life-threatening invasive fungal infection caused by certain emerging molds.
QIDP status provides priority review and a five-year extension of market exclusivity in the United States. In 2013, isavuconazole also received QIDP designation for the treatment of invasive aspergillosis, a severe fungal infection caused by widespread molds. These incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act.
