VIENNA (dpa-AFX) - Basilea Pharmaceutica Ltd. (BPMUF.PK) announced that the European Medicines Agency (EMA) has accepted its isavuconazole Marketing Authorization Application (MAA) for review. Basilea's MAA seeks approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis) in adults.
The company said the EMA will review the application under the centralized marketing authorization procedure. If approved by the EMA, isavuconazole would receive marketing authorization in all 28 member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
Basilea holds full rights to isavuconazole in markets outside of the U.S. and Canada where Astellas Pharma Inc. (ALPMY, ALPMY), the company's co-development partner, is the exclusive license holder.
Copyright RTT News/dpa-AFX