Astellas Gains QIDP Status from the FDA for Isavuconazol
Astellas reports that the US Food and Drug Administration (FDA) designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for the treatment of invasive candidiasis.
An invasive fungal infection 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 US Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act.
Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed for the treatment of severe invasive and life-threatening fungal infections. Isavuconazole is the active moiety of the prodrug isavuconazonium sulfate.
Isavuconazole is being co-developed with Basilea Pharmaceutica International Ltd., which is headquartered in Basel, Switzerland, and is focused on developing antibiotics, antifungals, and oncology drugs