BioCentury
ARTICLE | Clinical News

Isavuconazole: Phase III data

October 7, 2013 7:00 AM UTC

Top-line data from the double-blind, international Phase III SECURE trial in 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi showed that once-daily isavuconazole met the primary endpoint of non-inferiority to twice-daily voriconazole in the rate of all-cause mortality through day 42 (18.6% vs. 20.2%). Basilea and Astellas said the pre-specified non-inferiority margin was 10%. On a secondary endpoint, isavuconazole and voriconazole led to similar overall success rates on a composite of clinical, mycological and radiological responses at day 84 (35% vs. 36.4%). Astellas said the trial was not powered to show non-inferiority or superiority on the overall success rate endpoint. The most common adverse events reported were nausea, vomiting, pyrexia, diarrhea and hypokalemia. ...