Isavuconazole: Phase III ongoing

Basilea said it will amend the double-blind, international Phase III ACTIVE trial of isavuconazole to reduce enrollment to 438 patients from 526. The company said a recent blinded assessment of interim data showed a higher rate of evaluable patients than planned, allowing for a lower target enrollment while "preserving sufficient statistical power" of the primary endpoint. ACTIVE is comparing IV and oral isavuconazole vs. IV caspofungin followed by oral voriconazole.

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. ...