Astellas announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis.
An FDA orphan drug designation provides several benefits to the sponsor including a seven-year period of market exclusivity in the United States, should the FDA grant orphan drug exclusivity at approval. The FDA has previously granted orphan drug designation for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.
"Invasive candidiasis is a serious hospital-acquired fungal infection that is associated with increased morbidity and mortality in certain immunocompromised patients. Increasing reports of Candida resistance to available therapies necessitates the development of new antifungals to treat these serious infections," said Bernie Zeiher, M.D., executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. "The FDA's decision to grant isavuconazole orphan drug status underscores the growing need for additional tools to treat invasive candidiasis."
Previously, the FDA also designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for invasive candidiasis, invasive aspergillosis and invasive mucormycosis. QIDP status provides priority review and a five-year extension of market exclusivity in the United States. QIDP incentives were established under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act.