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FDA Committee Recommends Approval of Isavuconazonium (Cresemba) for Treatment of Invasive Aspergillosis and Mucormycosis

Agency’s decision expected in March

The FDA’s Anti-infective Drugs Advisory Committee has voted unanimously to recommend approval of once-daily intravenous and oral broad-spectrum isavuconazonium (Cresemba, Astellas Pharma) for the treatment of invasive aspergillosis, and 8 to 2 with one abstention to recommend approval of the drug for the treatment of invasive mucormycosis (also known as zygomycosis). Both are life-threatening fungal infections that predominantly occur in immunocompromised patients, such as patients with leukemia.

The committee's recommendation was based on data from the isavuconazonium development program, which included analyses from two phase III trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of isavuconazonium in adult patients with invasive aspergillosis; and VITAL, an open-label non-comparative study of isavuconazonium in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other rare fungi.

The FDA’s Anti-infective Drugs Advisory Committee provides the agency with independent expert advice and recommendations. The FDA is not bound by the committee's guidance, but its input will be considered by the agency in its review of the new drug application (NDA) for isavuconazonium, which was submitted on July 8, 2014. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected to be complete by March 8, 2015.

Invasive aspergillosis and mucormycosis are both known for their high morbidity and mortality.

Source: Astellas Pharma; January 22, 2015.


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