Isavuconazole filed with the FDA for Fungal Infections-Astellas

Astellas has submitted a New Drug Application to the FDA seeking approval for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening Fungal Infections predominantly occurring in immunocompromised patients. The submission is based on data from a Phase III invasive aspergillosis study, in which isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42.

The treatment-emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the System Organ Classes of hepatobiliary, skin and eye disorders. In both treatment groups, the most common treatment emergent adverse events were nausea, vomiting, pyrexia (fever) and diarrhea. In February, the FDA designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for invasive mucormycosis.