FDA Committee Recommends Antifungal Treatment Approval

The FDA’s Anti-Infective Drugs Advisory Committee has recommended the approval of Astellas’ investigational antifungal drug, isavuconazonium (Cresemba), for the treatment of invasive aspergillosis and mucormycosis, which are life-threatening fungal infections primarily found in immunocompromised patients.

While the FDA committee voted unanimously to recommend the approval of once-daily intravenous and oral broad-spectrum Cresemba for the treatment of invasive aspergillosis, they voted 8 to 2 with 1 abstention to recommend approval of the drug for the treatment of invasive mucormycosis, also known as zygomycosis.

The committee’s recommendations were based on data from the Cresemba development program, which included a randomized, double-blind, active-control study of adult patients with invasive aspergillosis and an open-label noncomparative study of Cresemba among adult patients with invasive aspergillosis and renal impairment or those who have contracted other invasive fungal diseases.

“We’re pleased with today’s positive recommendation for the approval of Cresemba for both indications,” Astellas’ executive vice president Bernie Zeiher, MD, said in a press release. “We look forward to working with the FDA to bring this important new therapy to patients to address an unmet need in the treatment of these life-threatening infections.”

While the committee’s recommendations are not binding, the FDA will take them into consideration in its review of Cresemba’s new drug application, which is expected to be completed by March 8, 2015, according to a press release.