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FDA committee recommends approval of Astellas’ Cresemba

The US Food and Drug Administration’s (FDA) Anti-infective Drugs Advisory Committee voted unanimously to recommend approval of Astellas' investigational once-daily intravenous and oral broad-spectrum Cresemba (isavuconazonium) to treat invasive aspergillosis and mucormycosis.

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

The committee’s recommendation was based on data from the Cresemba development program, which included analyses from two Phase III clinical trials in adult patients with invasive fungal infections.

First was the randomized, double-blind, active-control SECURE trial in adult patients with invasive aspergillosis, while the other was an open-label non-comparative trial called VITAL of Cresemba in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other rare fungi.

Astellas executive vice-president of Global Development and therapeutic area head of Infectious Disease Bernie Zeiher said: "We’re pleased with today’s positive recommendation for the approval of Cresemba for both indications.

"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."

The committee provides FDA with independent expert advice and recommendations, and its input will be considered by the Agency in its review of the Cresemba new drug application (NDA), which the company filed in July 2014.

The company is a jointly developing Cresemba with Basilea Pharmaceutica International.

In July 2014, Basilea submitted a European marketing authorization application (MAA) for Cresemba to treat invasive aspergillosis and mucormycosis in adults.