Astellas’ isavuconazole gets FDA orphan drug status to treat invasive candidiasis

An active moiety of the prodrug isavuconazonium, Isavuconazole is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed to treat severe invasive and life-threatening fungal infections.

The drug showed in-vitro and in-vivo coverage of a broad range of yeasts and molds as well as activity against emerging and often fatal molds including those that cause mucormycosis.

In the Phase III invasive aspergillosis trial, isavuconazole showed non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42.

The drug also showed efficacy in the treatment of invasive Mucormycosis in an open-label Phase III trial.

Nausea, vomiting, diarrhea, headache, elevated liver chemistry tests, hypokalemia, abdominal pain, dyspnea, edema peripheral, and constipation were the adverse reactions of isavuconazole most frequently observed in therapeutic clinical trials.

Astellas executive vice-president of Global Development and therapeutic area head of Infectious Disease Bernie Zeiher said: "Invasive candidiasis is a serious hospital-acquired fungal infection that is associated with increased morbidity and mortality in certain immunocompromised patients.

"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."