Astellas Pharma announced that the FDA has designated isavuconazole a Qualified Infectious Disease Product (QDIP) for the treatment of invasive aspergillosis. Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal.
In addition to the QDIP designation, isavuconazole also has received Fast Track and Orphan Drug designation for the treatment of zygomycosis, a life-threatening invasive fungal infection (IFI) caused by emerging molds and invasive aspergillosis.
Isavuconazole is currently in Phase 3 of clinical development. The Phase 3 program with isavuconazole includes three studies, SECURE, VITAL, and ACTIVE. Positive top-line results were reported from the SECURE study, a global randomized, double-blind phase 3 study, designed to evaluate the safety and efficacy of once-daily isavuconazole vs. twice-daily voriconazole in the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi. Isavuconazole demonstrated non-inferiority vs. voriconazole. Isavuconazole was effective as determined by the primary endpoint of all-cause mortality through day 42 in the intent-to-treat population (N=516).
The VITAL study is an open-label Phase 3 study including patients with invasive fungal disease caused by emerging fungal pathogens such as Zygomycetes and patients with aspergillosis and pre-existing renal impairment. Enrollment into VITAL has been completed (N=150).
The Phase 3 ACTIVE study is a randomized, double-blind study evaluating the use of isavuconazole intravenous and oral vs. caspofungin intravenous followed by oral voriconazole for the treatment of invasive Candida infections. The ACTIVE study is still recruiting patients.
For more information call (877) 829-7942 or visit Astellas.com.