Isavuconazole NDA Submitted for Invasive Fungal Infections
Astellas announced that it has submitted a New Drug Application (NDA) to the FDA for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis. 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.
In the Phase 3 invasive aspergillosis study, isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42.
Previously in February, the FDA designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for invasive mucormycosis. QIDP designation for the treatment of invasive aspergillosis was granted last year. Also, in 2013, isavuconazole was granted Orphan Drug status for invasive aspergillosis and invasive mucormycosis.
For more information call (877) 829-7942 or visit Astellas.com.