Briefing Summary: US FDA Posts Advisory Committee Materials for Review of Astellas’ Isavuconazole for Invasive Aspergillosis and Mucormycosis – JAN 22, 2015 (AIDAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Thursday, January 22, 2015 Anti-Infective Drugs Advisory Committee (AIDAC) Meeting. The committee will discuss new drug applications (NDAs) 207-500 and 207-501 for isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc. (Astellas), for the proposed indications of treatment of invasive aspergillosis and mucormycosis. The drugs are being co-developed with Basilea Pharmaceutica Ltd., a company that holds full rights to isavuconazole in markets outside of the U.S. and Canada. Astellas is the exclusive license holder in the U.S.