ARTICLE | Clinical News

Isavuconazole regulatory update

September 15, 2014 7:00 AM UTC

The companies said FDA accepted for review an NDA from Astellas for isavuconazole to treat invasive aspergillosis and mucormycosis (zygomycosis). The PDUFA date is March 8, 2015. The acceptance triggers a CHF12 million ($12.9 million) milestone payment from Astellas to Basilea. An MAA for the broad-spectrum water-soluble azole antifungal is also under review in the EU, with a decision expected 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, for which it is in Phase III testing. ...