BioCentury
ARTICLE | Company News

FDA briefing docs benign for Astellas, Basilea antifungal

January 21, 2015 4:58 AM UTC

FDA reviewers offered little commentary on Cresemba isavuconazonium ( BAL8557) from Astellas Pharma Inc. (Tokyo:4503) in voriconazole.

In the 516-patient double-blind Phase III SECURE trial for aspergillosis, isavuconazole met the primary endpoint of non-inferiority to voriconazole in the rate of all-cause mortality through day 42 (18.6% vs. 20.2%). In a subgroup of 37 patients with mucormycosis in the 149-patient open-label Phase III VITAL trial, overall mortality was 37.8% at day 42 and 43.2% at day 84, the co-primary endpoints. The pharma also included a review of scientific literature and matched controls to support efficacy vs. amphotericin B deoxycholate, the only FDA-approved drug for invasive mucormycosis. ...