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ARTICLE | Company News

FDA approves antifungal Cresemba

March 7, 2015 2:23 AM UTC

FDA approved an NDA from Astellas Pharma Inc. (Tokyo:4503) for oral and IV Cresemba isavuconazonium sulfate to treat adults with invasive aspergillosis and mucormycosis. The broad-spectrum water-soluble azole antifungal was under Priority Review, and has Qualified Infectious Disease Product (QIDP) and Orphan Drug status for both indications. Astellas declined to discuss launch plans.

Astellas obtained rights to Cresemba in the U.S. and Canada from originator Basilea Pharmaceutica AG (SIX:BSLN), which retains rights elsewhere under an amended 2010 deal. ...