FDA
3rd February 2015

FDA Panel Supports Approval of Antifungal Isavuconazonium (Cresemba)

The committee also voted eight to two with one abstention to recommend approval of Cresemba to treat invasive mucormycosis (also known as zygomycosis).

FDA Panel Supports Approval of Antifungal Isavuconazonium (Cresemba)

On January 22nd, the Anti-Infective Drugs Advisory Committee (AIDAC) voted unanimously to recommend the approval of Cresemba (isavuconazonium) from Japan-based Astellas Pharma and its partner Basilea Pharmaceutica for the treatment of invasive aspergillosis.

The committee also voted eight to two with one abstention to recommend approval of Cresemba to treat invasive mucormycosis (also known as zygomycosis).

This recommendation is based on data from the Cresemba development program, which included analyses from two Phase III trials, SECURE and VITAL, which involved adult patients with invasive fungal infections. SECURE was a global, multicenter, randomized, double-blind, controlled noninferiority study that compared isavuconazonium to voriconazole in patients with invasive aspergillosis. VITAL was an open-label, multicenter, single-arm study in patients with invasive aspergillosis and renal impairment or patients with invasive fungal disease caused by rare molds, yeasts, or dimorphic fungi. 

Furthermore, enrollment for another phase 3 study, ACTIVE, which assesses isavuconazole in the treatment of candidemia and other invasive Candida infections, was recently completed in January 2015, and topline data are anticipated later this year following completion of treatment and follow-up periods.

Invasive aspergillosis and mucormycosis are life-threatening fungal infections predominantly occurring in immunocompromised patients.

Voting member Yu Shyr, PhD, from Vanderbilt University School of Medicine, Nashville, Tennessee noted, “Overall, I think the quality of the data is…quite good.” 

Currently, isavuconazole is not approved for commercial use in any world markets, but is currently under review by both the FDA and the EMA for the aforementioned indications. The regulatory review of the Marketing Authorization Application (MAA) (specific to the EMA), which was submitted by Basilea on July 16, 2014, is anticipated to be completed in the fourth quarter of 2015.

The FDA has granted orphan drug status to isavuconazonium for invasive aspergillosis and mucormycosis, and is expected to complete its review of the isavuconazole NDA by March 2015. The FDA is not obligated to follow the advice of its advisory committee panels, but normally does so.

 

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