Isavuconazole filed with EU for Fungal Infections-Basilea Pharma

Basilea Pharmaceutica has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of Fungal Infections - invasive aspergillosis and mucormycosis (zygomycosis). Basilea's co-development partner Astellas Pharma recently submitted a New Drug Application (NDA) for isavuconazole to the FDA.

The MAA is supported by data from the SECURE and VITAL Phase III studies. In the invasive aspergillosis SECURE study, 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 addition, isavuconazole showed statistically fewer study drug-related adverse events relative to voriconazole. The VITAL study was an open-label study of isavuconazole (N=149 patients) in the treatment of aspergillosis patients with pre-existing renal impairment or patients with invasive fungal disease caused by emerging and often fatal molds such as Mucorales, yeasts, or dimorphic fungi. Initial results show that day 42 all-cause mortality in renally-impaired patients with invasive aspergillosis was 16.7%.