Astellas today announced that the U.S. Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis, a life-threatening, invasive fungal infection.
A product that is granted QIDP status receives a priority review and a five-year extension of market exclusivity in the United States. Previously, isavuconazole received QIDP designation for invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). The incentives for all three conditions were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act.
"The need to treat serious fungal infections can be one of life or death. This QIDP designation, along with the previous two we have received, emphasizes how important it is to patients and their families that products are available to treat these infections," said Bernie Zeiher, Executive Vice President, Global Development and Therapeutic Area Head of Infectious Disease at Astellas.