FDA's anti-infective committee recommends Astellas' Cresemba

The US Food and Drug Administration’s Anti-Infective Drugs Advisory Committee has voted unanimously to recommend the approval of Cresemba (isavuconazonium) from Japan's Astellas Pharma (TYO: 4503) and its partner Basilea Pharmaceutica (SIX: BSLN) for invasive aspergillosis.

The committee also voted eight to two with one abstention to recommend the approval of Cresemba to treat invasive mucormycosis.

This recommendation is based on data from the Cresemba development program, which included analyses from two Phase III trials in adult patients with invasive fungal infections. SECURE was 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.