ARTICLE | Clinical News

Isavuconazole regulatory update

November 17, 2014 8:00 AM UTC

FDA granted Orphan Drug designation to isavuconazole to treat invasive candidiasis. Isavuconazole is under FDA and EMA review to treat invasive aspergillosis and mucormycosis (zygomycosis). The NDA has a PDUFA date of March 8, 2015, and a decision is expected on the MAA by 4Q15. The product has Orphan Drug designation in the U.S. and EU and Qualified Infectious Disease Product (QIDP) designation in the U.S. for the 2 indications. Isavuconazole also has Fast Track designation in the U.S. to treat invasive fungal infections in patients with moderate to severe renal impairment and QIDP designation to treat invasive candidiasis. ...