PDUFA Action Date for Astellas enzalutamide; Urogenix facility to close

The US Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 22, 2012, for the review of the investigational agent enzalutamide (formerly MDV3100) New Drug Application for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

Japanese drug major Astellas (TYO: 4503) acquired rights to the prostate drug candidate from USA-based Medivation (Nasdaq: MDVN) under an agreement worth a potential $765 million to the US firm (The Pharma Letter October 27, 2009). Medivation and Astellas announced the submission of a New Drug Application for enzalutamide to the FDA earlier this year (The Pharma Letter May 23).

Enzalutamide is an oral, once-daily investigational agent that is an androgen receptor signaling inhibitor. Enzalutamide inhibits androgen receptor signaling in three distinct ways: it inhibits testosterone binding to androgen receptors; nuclear translocation of androgen receptors; and DNA binding and activation by androgen receptors.