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Isavuconazole granted orphan drug status
The FDA has granted orphan drug status to isavuconazole for the treatment of invasive candidiasis/candidemia, according to a press release from Basilea Pharmaceutica.
Isavuconazole (Basilea,Astellas) previously was designated as an orphan drug in the European Union and the United States to treat invasive aspergillosis and mucormycosis. Among the benefits of an FDA orphan drug designation is a 7-year period of market exclusivity in the United States if approved.
The FDA designated March 8 for the completion of the US New Drug Application review, according to the release. Completion of the European Marketing Authorization Application is expected in the fourth quarter of 2015.
The antifungal agent also has been designated as a Qualified Infectious Disease Product by the FDA under the GAIN Act for the treatment of invasive aspergillosis, mucormycosis and candidiasis. This status allows for priority review and a 5-year extension of market exclusivity if the drug is approved.