Cresemba (isavuconazole) has Advisory Committee recommendation for Invasive Aspergillosis, and Zygomycosis-Astellas+ Basilea

Basilea Pharmaceutica Ltd. announced that the FDA Anti-Infective Drugs Advisory Committee voted unanimously to recommend approval of the investigational once-daily intravenous and oral antifungal isavuconazole, the active moiety of the prodrug isavuconazonium sulfate, for the treatment of invasive aspergillosis, and eight to two with one abstention to recommend approval for the treatment of invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients. Basilea's partner Astellas presented the data to the FDA and, if approved, intends to market the drug as Cresemba in the United States. The Advisory Committee's recommendation is based on data from the isavuconazole development program, which included analyses from two phase III clinical trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of adult patients with invasive aspergillosis, and VITAL, an open-label non-comparative study of isavuconazole in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other fungi, including those causing mucormycosis.

The European regulatory review of the Marketing Authorization Application (MAA), which was submitted by Basilea on July 16, 2014, is anticipated to be completed in the fourth quarter of 2015.

Comment: Patients who suffer from invasive fungal infections and those with adjunct renal dysfunction in particular, have limited treatment options. Isavuconazole may fulfill these patients' severe medical need for an IV or oral antifungal agent that has the potential for less drug-drug interactions than a number of other drugs in current use.