Medivation, Inc. (MDVN: Quote) and Astellas Pharma Inc. said Friday that the U.S. Food and Drug Administration has approved Xtandi capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel.
The FDA accepted the Xtandi new drug application on July 23, and granted the filing priority review designation with a Prescription Drug User Fee Act action date of November 22.
Medivation and Astellas expect to make Xtandi available to patients in the United States in mid-September.
The recommended dose of Xtandi is 160 mg, four 40 mg capsules, administered orally once daily. The drug can be taken with or without food and does not require concomitant steroid (e.g., prednisone) use.
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. The companies have agreed to provide the data from the study in 2019.
A marketing authorization application for Xtandi has been accepted for review by the European Medicines Agency, Medivation revealed.
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