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FDA panel backs Astellas-Basilea antifungal

January 23, 2015 2:17 AM UTC

FDA's Anti-Infective Drugs Advisory Committee on Thursday backed approval of Cresemba isavuconazonium ( BAL8557) from Astellas Pharma Inc. (Tokyo:4503) to treat invasive aspergillosis and mucormycosis in adults. The committee voted 11-0 that Astellas provided substantial evidence of Cresemba's safety and efficacy for aspergillosis, and 8-2, with one abstention, for mucormycosis. Both are rare fungal infections.

Astellas is seeking approval for the aspergillosis indication based primarily on data from the 516-patient double-blind Phase III SECURE trial, where 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%). Isavuconazonium is a prodrug of isavuconazole, a broad-spectrum water-soluble azole antifungal. ...