Background Analysis: US FDA Advisory Committee to Review Astellas’ Isavuconazole for Invasive Aspergillosis and Mucormycosis – JAN 22, 2015 (AIDAC)
The US FDA has scheduled an Anti-Infective Drugs Advisory Committee (AIDAC) Meeting for Thursday, January 22, 2015 to discuss new drug applications (NDAs) 207-500 and 207-501, 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 U.K. 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.