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Isavuconazole (Cresemba) Wins FDA Approval for Treatment of Aspergillosis and Mucormycosis

Azole antifungal agent reduces mortality in phase III studies

The FDA has given the nod to a new drug application for the use of isavuconazole (Cresemba, Basilea Pharmaceutica/Astellas) in the treatment of invasive aspergillosis and invasive mucormycosis in patients 18 years of age or older.

Isavuconazole is an azole antifungal and the active agent of the prodrug isavuconazonium sulfate.

The safety and efficacy profiles of isavuconazole in patients with invasive aspergillosis were determined in two phase III clinical trials in adults with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of patients with invasive aspergillosis; and VITAL, an open-label noncomparative study of isavuconazole in patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other fungi, including those causing mucormycosis.

In the SECURE study, isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42 for the treatment of invasive aspergillosis or other filamentous fungi in 516 patients. The all-cause mortality rate through day 42 was 18.6% in the isavuconazole group compared with 20.2% in the voriconazole group.

The VITAL trial included 37 patients with invasive mucormycosis treated with isavuconazole. The all-cause mortality rate in this study was 38%. The efficacy of isavuconazole for the treatment of invasive mucormycosis has not been evaluated in concurrent, controlled clinical trials.

The most common adverse events for patients treated with isavuconazole in both trials included 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%).

Invasive aspergillosis is a life-threatening fungal infection that predominantly affects immunocompromised patients, such as those with leukemia. Invasive mucormycosis (also known as zygomycosis) is a rapidly progressing and life-threatening invasive fungal infection. Both diseases are known for their high morbidity and mortality.

Source: Basilea Pharmaceutica; March 6, 2015.

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