FDA approves Cresemba for Fungal Infections-Astellas

The FDA has approved the New Drug Application (NDA) for the use of Cresemba (isavuconazonium sulfate), the prodrug for isavuconazole, from Astellas, for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).

The safety and efficacy profile of Cresemba in patients with invasive aspergillosis was demonstrated based on data from two Phase III clinical trials in adult patients with invasive fungal infections: SECURE and VITAL. In the SECURE study, Cresemba demonstrated non-inferiority 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 percent in the Cresemba treatment group and 20.2 percent in the voriconazole treatment group. The safety and efficacy profile of Cresemba in patients with invasive mucormycosis was demonstrated based on data from the VITAL study. All-cause mortality in Cresemba-treated patients was 38 percent. The efficacy of Cresemba for the treatment of invasive mucormycosis has not been evaluated in concurrent, controlled clinical trials.

In the SECURE study, the overall safety profile for Cresemba demonstrated similar rates of mortality and non-fatal adverse events as the comparator, voriconazole. The most frequent adverse events for patients treated with Cresemba 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%).

Comment: The therapy will compete against Pfizer’s Vfend (voriconazole). These life-threatening invasive fungal infections (invasive aspergillosis and mucormycosis (zygomycosis)) predominantly occur in immunocompromised patients. Invasive aspergillosis is estimated to occur in 5-13% of bone marrow transplant recipients, 5-25% of patients who have received heart or lung transplants, and 10-20% of patients who have received intensive chemotherapy for leukemia.