FDA Approves Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis and Invasive Mucormycosis


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The U.S. Food and Drug Administration (FDA) has approved Astellas’ New Drug Application for the use of isavuconazonium sulfate (Cresemba), the prodrug for isavuconazole, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). These are life-threatening fungal infections predominantly occurring in immunocompromised patients.

The safety and efficacy profile of isavuconazonium sulfate in patients with invasive aspergillosis and invasive mucormycosis was demonstrated based on data from the Cresemba development program. The safety and efficacy profile of isavuconazonium sulfate in patients with invasive aspergillosis was demonstrated based on data 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 noncomparative study of isavuconazonium sulfate in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other rare fungi.

Study Details

In the SECURE study (a study of 516 patients), isavuconazonium sulfate demonstrated noninferiority to voriconazole on the primary endpoint of all-cause mortality at day 42 for the treatment of adult patients with invasive aspergillosis or other filamentous fungi. All-cause mortality through day 42 was 18.6% in the isavuconazonium sulfate treatment group and 20.2% in the voriconazole treatment group.

The safety and efficacy profile of isavuconazonium sulfate in patients with invasive mucormycosis was demonstrated based on data from the VITAL study, which included a subpopulation of 37 patients with invasive mucormycosis treated with isavuconazonium sulfate. All-cause mortality in isavuconazonium sulfate–treated patients was 38%. The efficacy of isavuconazonium sulfate for the treatment of invasive mucormycosis has not been evaluated in concurrent, controlled clinical trials.

Safety Profile

In the SECURE study, the overall safety profile for isavuconazonium sulfate demonstrated similar rates of mortality and nonfatal adverse events as the comparator, voriconazole. The most frequent adverse events for patients treated with isavuconazonium sulfate in clinical trials were: nausea (26%), vomiting (25%), diarrhea (22%), headache (17%), elevated liver chemistry tests (17%), hypokalemia (14%), constipation (13%), dyspnea (12%), cough (12%), peripheral edema (11%), and back pain (10%). ■

 



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