Basilea reports U.S. FDA approval of isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis - Seite 2

In the SECURE study (a study of 516 patients), isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at Day 42 for the treatment of patients with invasive aspergillosis or other filamentous fungi. All-cause mortality through Day 42 was 18.6 percent in the isavuconazole treatment group and 20.2 percent 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 invasive mucormycosis treated with isavuconazole. All-cause mortality in isavuconazole-treated patients was 38 percent. The efficacy of isavuconazole for the treatment of invasive mucormycosis has not been evaluated in concurrent, controlled clinical studies.

In the SECURE study, the overall safety profile for isavuconazole demonstrated similar rates of mortality and non-fatal adverse events as the comparator, voriconazole. Further, isavuconazole showed statistically fewer study drug-related adverse events relative to voriconazole in invasive aspergillosis patients.¹ In addition, treatment-emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the system organ classes of hepatobiliary, skin and eye disorders.²

The most frequent adverse events for patients treated with isavuconazole 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%).

About invasive aspergillosis and invasive mucormycosis

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

About isavuconazole

Isavuconazole is an azole antifungal and the active agent of the prodrug isavuconazonium sulfate. The drug is indicated in the U.S. for use in the treatment of invasive aspergillosis and invasive mucormycosis in adults. Outside the U.S., isavuconazole is an investigational product and currently not approved for commercial use. A European Marketing Authorization Application, submitted by Basilea, for isavuconazole for the treatment of invasive aspergillosis and mucormycosis in adults, is currently under review by the European Medicines Agency.