Medivation, Inc. (MDVN) and Astellas Pharma Inc. announced that Astellas has submitted a Marketing Authorisation Application or MAA to the European Medicines Agency or EMA for enzalutamide (formerly MDV3100) for the treatment of men with metastatic castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. A New Drug Application or NDA has been submitted in the United States, where priority review of the compound has been requested.
For comments and feedback: editorial@rttnews.com