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Medivation Inc And Astellas Pharma Inc Announce U.S. FDA Approves XTANDI


Friday, 31 Aug 2012 02:15pm EDT 

Medivation Inc and Astellas Pharma Inc announced that the U.S. Food and Drug Administration (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. The recommended dose of XTANDI is 160 mg (four 40 mg capsules) administered orally once daily. XTANDI can be taken with or without food and does not require concomitant steroid (e.g., prednisone) use. In the phase 3 clinical trial, 48% of XTANDI patients and 46% of patients in the placebo arm were treated with glucocorticoids. 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. 

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28 Jul 2014