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Basilea Pharmaceutica AG And Astellas Pharma Inc Reports Positive Topline Phase 3 Results For Antifungal Isavuconazole


Monday, 30 Sep 2013 01:36am EDT 

Basilea Pharmaceutica AG announced positive topline data from the isavuconazole phase 3 invasive aspergillosis study (SECURE). The antifungal agent isavuconazole is being co-developed with Astellas Pharma Inc. The randomized, double-blind isavuconazole study (SECURE) 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. The 95% confidence interval of the treatment difference between isavuconazole and voriconazole was within the pre-specified non-inferiority margin of 10%.