FDA Anti-infective Drug Panel recommends approval of Astellas’ new antifungal treatment

WASHINGTON - Jan. 23, 2015 - PRLog -- The U.S. Food and Drug Administration's (FDA) Anti-infective Drugs Advisory Committee reached a unanimous decision to recommend approval of Astellas’ CRESEMBA® (isavuconazonium) an investigational treatment for mucormycosis (also known as zygomycosis), which is a rare fungal infection occurring in people with weakened immune systems.

"We're pleased with today's positive recommendation for the approval of CRESEMBA for both indications," said Bernie Zeiher, M.D., executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. "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’s decision stems from clinical data collected from two phase 3 studies : SECURE, a randomized, double-blind, active-control study evaluating patients with invasive aspergillosis ; and  VITAL, an open-label non-comparative study assessing CRESEMBA in adult patients with invasive aspergillosis and renal impairment or patients who have an invasive fungal disease caused by other rare fungi.

The FDA’s review of the CRESEMBA New Drug Application NDA is expected to be complete by March 8, 2015. The drug is currently being co-developed with Basilea Pharmaceutical International Ltd which submitted an European Marketing Authorization Application on July 16, 2014.

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