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news.The US Food and Drug Administration (FDA) has accepted for filing Astellas' new drug application (NDA) for isavuconazole to treat invasive aspergillosis and invasive mucormycosis, also known as zygomycosis.
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These two are life-threatening fungal infections predominantly occurring in immunocompromised patients.
The FDA has designated the date of 8 March 2015 for the completion of the review, in accordance with the FDA Prescription Drug User Fee Act (PDUFA).
Isavuconazole was also designated as a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of both invasive aspergillosis and invasive mucormycosis.
The once-daily intravenous and oral broad-spectrum antifungal drug isavuconazole is 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.
Isavuconazole, the active moiety of the prodrug isavuconazonium sulphate, is being co-developed with Basilea Pharmaceutica International.