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.
In the event isavuconazole is approved in the United States, the five years QIDP market exclusivity would be in addition to the seven-year exclusivity based on isavuconazole's orphan drug designation for the treatment of zygomycosis that was granted by the FDA in 2013. In the U.S., isavuconazole also has FDA fast-track status and has received orphan drug designation for the treatment of invasive aspergillosis.
"Acceptance of this second QIDP designation for isavuconazole further demonstrates the importance of developing new agents such as isavuconazole for patients with serious or life threatening invasive fungal infections such as mucormycosis," said Bernie Zeiher, Senior Vice President and Global Therapeutic Area Head of Immunology and Infectious Diseases at Astellas Pharma Global Development, Inc.
Astellas Pharma Global Development, Inc.