Basilea Pharmaceutica Ltd. (BPMUF.PK) said Monday the U.S. Food and Drug Administration, or FDA, has granted orphan drug designation to isavuconazole, used for the treatment of invasive candidiasis/candidemia, a potentially life-threatening infection caused by Candida yeasts.
The orphan drug designation give several benefits to the sponsor, including a seven-year period of market exclusivity in the U.S.
Currently, Isavuconazole is under regulatory review by the U.S. FDA and the European Medicines Agency for the treatment of invasive aspergillosis and mucormycosis in adults.
The review of the new drug application is expected to be completed on March 8, 2015, while the review of the European Marketing Authorization Application is anticipated to be completed by the fourth quarter of 2015.
Isavuconazole is being co-developed with Astellas Pharma Inc. (ALPMY). Basilea holds full rights to isavuconazole in markets outside of the U.S. and Canada, where Astellas is the exclusive license holder.
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