Isavuconazole phase III trial demonstrates non inferiority versus voriconazole
October 03 2013
Astellas who developed the new antifungal drug isavuconazole, have published results from their phase III trials on the treatment of invasive aspergillosis, indicating favourable data for isavuconazole in comparison to voriconazole (Wall Street Journal report). "The randomized, double-blind isavuconazole study achieved its primary objective in demonstrating non-inferiority versus voriconazole for the primary treatment of invasive fungal disease caused by Aspergillus species or certain other filamentous fungi. 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 all-cause-mortality was 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole group". In the sample of 500 patients there was a 7% lower mortality and only 40% drug related adverse events with isavuconazole, compared to 60% drug-related adverse events for voriconazole.
The isavuconazole is given once daily compared to twice daily for voriconazole.
This indicates that isavuconazole may have significant advantages for treating invasive aspergillosis over voriconazole as many patients fail voriconazole therapy because of severe side effects. The overall effectiveness at the end of the study (42 days) was comparable and certainly no worse than using voriconazole, which bodes well for this new antifungal drug.