EU CHMP recommends approval of Cresemba (isavuconazole) for fungal infections- Basilea Pharma

The CHMP of the European Medicines Agency adopted a positive opinion recommending the approval of Cresemba (isavuconazole), from Basilea Pharma, for the treatment of adult patients with invasive aspergillosis and adult patients with mucormycosis for whom amphotericin B is inappropriate.

The positive CHMP opinion is based on results from the isavuconazole development program. The safety and efficacy profile of isavuconazole in adult patients with invasive aspergillosis was demonstrated based on data from two Phase III clinical studies: SECURE, a randomized, double-blind, active-control study in 516 patients with invasive aspergillosis, and VITAL, an open-label non-comparative 146-patient study of isavuconazole in renally impaired patients with invasive aspergillosis, or in patients with invasive fungal disease caused by other emerging fungi.

In the SECURE study, isavuconazole was non-inferior to voriconazole based on the primary endpoint of all-cause mortality at Day 42 in the intent-to-treat population. All-cause mortality through Day 42 was 18.6% in the isavuconazole treatment group and 20.2% in the voriconazole treatment group. The safety and efficacy profile of isavuconazole in patients with mucormycosis was demonstrated based on data from the VITAL study, which included a subpopulation of 37 patients with mucormycosis.