Medivation Inc. (MDVN)

[mlkrborn]

Medivation confirms FDA approved XTANDI (enzalutamide) after priority review for patients with metastatic castration-resistant prostate cancer previously treated with docetaxel (MDVN) 98.78 +1.36 : Co and Astellas Pharma (ALPMY.PK) announced that the FDA has granted approval to XTANDI (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel. XTANDI is an oral, once-daily androgen receptor inhibitor. The FDA accepted the XTANDI New Drug Application (NDA) on July 23, 2012, and granted the filing Priority Review Designation with a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012. Medivation and Astellas expect to make XTANDI available to patients in the United States in mid-September 2012, and the specific availability date will be announced on www.XtandiHCP.com as soon as it is known. Separately, a Marketing Authorization Application for XTANDI has been accepted for review by the European Medicines Agency. As a post-marketing requirement, Medivation and Astellas have agreed with the FDA to conduct an open-label safety study of XTANDI (160 mg/day) in patients who are at high risk for seizure. Medivation and Astellas have agreed to provide the data from this study in 2019.