The US Food and Drug Administration (FDA) has accepted Astellas’s new drug application (NDA) for the use of Cresemba (isavuconazonium sulfate) to treat aspergillosis and invasive mucormycosis (zygomycosis).
Cresemba’s NDA has been accepted for patients 18 years of age and older to treat aspergillosis and invasive mucormycosis, which are said to be life-threatening fungal infections predominantly occurring in immunocompromised patients.
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Astellas global development executive vice-president and infectious disease therapeutic area head Bernie Zeiher said: “We’re pleased with the FDA’s approval of Cresemba for use in treating patients with these life-threatening infections.”
The drug is being co-developed with Basilea Pharmaceutica International. Astellas submitted NDA in July 2014, while Basilea submitted a European marketing authorisation application in the same month to treat invasive aspergillosis and mucormycosis in adults.
Basilea will receive CHF30m ($30.4m) milestone payment from Astellas as part of their licence and co-development agreement, upon the approval.
Cresemba’s safety and efficacy profile in patients with invasive aspergillosis and invasive mucormycosis was demonstrated based on data from two Phase III clinical trials in adult patients with invasive fungal infections.
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By GlobalDataThe Secure trial is a randomised, double-blind, active-control study of adult patients with invasive aspergillosis, while Vital is 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.
Cresemba showed 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, in the Secure trial.
Its safety and efficacy profile in patients with invasive mucormycosis was demonstrated based on data from the Vital study, which included a subpopulation of 37 patients with invasive mucormycosis treated with Cresemba.
The overall safety profile for Cresemba demonstrated similar rates of mortality and non-fatal adverse events as the comparator, voriconazole, in the Secure study.
Image: Zygomycosis / mucormycosis. Photo: courtesy of Yale Rosen.
