Astellas submits isavuconazole NDA

Astellas Pharma Inc. (Tokyo:4503) submitted an NDA to FDA for isavuconazole to treat invasive aspergillosis and invasive mucormycosis (zygomycosis). The broad spectrum water-soluble azole antifungal has Qualified Infectious Disease Product (QIDP) designation in the U.S. for the indications. Partner Basilea Pharmaceutica AG (SIX:BSLN) plans to submit an MAA to EMA mid-year. ...