JAN 22 AIDAC

Results Wire: US FDA Advisory Committee Supports Astellas’ Isavuconazole for Invasive Aspergillosis and Mucormycosis – JAN 22, 2015 (AIDAC)

On Thursday, January 22, 2015 the Anti-Infective Drugs Advisory Committee (AIDAC) unanimously supported, by a vote of 11-Yes to 0-No, the safety and efficacy of isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, sponsored by Astellas Pharma Global Development, Inc. (Astellas), for the proposed indication of the treatment of invasive aspergillosis.

In addition, the AIDAC supported, by a vote of 8-Yes to 2-No, with one abstention, the safety and efficacy isavuconazonium sulfate capsules and isavuconazonium sulfate for injection, by Astellas, for the proposed indication of the treatment of invasive mucormycosis.

See the SAC Tracker Report