The prodrug for isavuconazole, Cresemba has been approved for use in patients aged 18 years and above in the treatment of zygomycosis, which are life-threatening fungal infections predominantly occurring in immunocompromised patients.
Astellas Global Development executive vice-president and Infectious Disease therapeutic area head Dr Bernie Zeiher said: "We’re pleased with the FDA’s approval of Cresemba for use in treating patients with these life-threatening infections.
"We are proud to be able to offer a new treatment for patients in an area for which there is a significant unmet medical need."
Cresemba’s safety and efficacy profile in patients with invasive aspergillosis was demonstrated based on data from two Phase 3 clinical trials in adult patients with invasive fungal infections.
The SECURE study was a randomized, double-blind, active-control study of adult patients with invasive aspergillosis; and VITAL was an open-label non-comparative study of cresemba in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other rare fungi.
However, the drug’s efficacy for the treatment of invasive mucormycosis has not been evaluated in concurrent, controlled clinical trials.
The recommended loading dose of cresemba is one reconstituted vial or two capsules (372mg isavuconazonium sulfate equivalent to 200mg of isavuconazole) every eight hours for six doses (48 hours) via oral or intravenous administration.
The recommended maintenance dose is one reconstituted vial or two capsules (372mg isavuconazonium sulfate equivalent to 200mg of isavuconazole) once per day via oral or intravenous administration, starting 12 to 24 hours after the last loading dose.
The new therapy is being co-developed with Basilea Pharmaceutica International as part of a license and co-development agreement between the firms. Astellas will now pay a CHF30m milestone payment to Basilea.
Basilea has submitted a European Marketing Authorization Application for the drug on 16 July 2014 for the treatment of invasive aspergillosis and mucormycosis in adults.