Antifungal Receives FDA Orphan Drug Designation for Invasive Candidiasis

Astellas today announced that the FDA has granted orphan drug designation to isavuconazole for the treatment of invasive candidiasis, one of the most frequent invasive fungal infections detected in critically ill patients and a common cause of bloodstream infections.

"Invasive candidiasis is a serious, hospital-acquired fungal infection that is associated with increased morbidity and mortality in certain immunocompromised patients,” said Bernie Zeiher, executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas, in a press release. “Increasing reports of Candida resistance to available therapies necessitates the development of new antifungals to treat these serious infections. The FDA's decision to grant isavuconazole orphan drug status underscores the growing need for additional tools to treat invasive candidiasis."

The FDA formerly designated the investigational once-daily intravenous and oral broad-spectrum antifungal as a Qualified Infectious Disease Product for invasive candidiasis, invasive aspergillosis, and invasive mucormycosis. The agency also previously granted orphan drug designation to isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.

In a phase 3 trial, isavuconazole demonstrated non-inferiority to Pfizer’s voriconazole (Vfend) antifungal drug on all-cause mortality at day 42. Additionally, isavuconazole has demonstrated in-vitro and in-vivo coverage of a broad range of molds and yeasts, including the Candida species.

Adverse effects associated with the antifungal treatment include headache, nausea, vomiting, and diarrhea.

Isavuconazole is currently being co-developed with Basilea Pharmaceutica International Ltd.