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news.Astellas Pharma Global Development, a subsidiary of Japanese pharmaceutical firm Astellas Pharma has received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) for its isavuconazole for the treatment of invasive mucormycosis (also known as zygomycosis).
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Invasive mucormycosis is a life-threatening invasive fungal infection caused by certain emerging molds.
The designation provides priority review and a five-year extension of market exclusivity in the US.
In 2013, isavuconazole also secured QIDP designation for the treatment of invasive aspergillosis, a severe fungal infection caused by widespread molds.
The five years QIDP market exclusivity would be in addition to the seven-year exclusivity based on the drug’s orphan drug designation for the treatment of zygomycosis that was granted by the FDA in 2013.
In the US, the drug also has FDA fast-track status and has secured orphan drug designation for the treatment of invasive aspergillosis.
Astellas Pharma Global Development senior vice president and global therapeutic area head of Immunology and Infectious Diseases Bernie Zeiher said, "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."
Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of severe invasive and life-threatening fungal infections.
Currently, the drug is in Phase III of clinical development.