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Janssen Submits Additional Marketing Applications for ZYTIGA® in the U.S. and European Union
Date:6/15/2012

RARITAN, N.J., June 15, 2012 /PRNewswire/ -- Janssen Research & Development, LLC announced today it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for ZYTIGA® (abiraterone acetate); simultaneously, Janssen-Cilag International NV has submitted a type II variation to the European Medicines Agency (EMA).  Both applications are intended to extend the use of ZYTIGA administered with prednisone to include the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and before chemotherapy.  

ZYTIGA in combination with prednisone was approved in the U.S. in April 2011 and in the European Union in September 2011 for the treatment of men with mCRPC who have received prior docetaxel-based chemotherapy.  Since its first approval in the U.S. in 2011, ZYTIGA has been approved in more than 45 countries. The sNDA filing was completed by Janssen Research & Development on behalf of Janssen Biotech, Inc., the U.S. marketer of ZYTIGA.

Both regulatory applications follow the announcement of results observed from pre-specified interim analyses of the international Phase 3, randomized, double-blind, placebo-controlled COU-AA-302 clinical study.  This study, which included 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy, evaluated the efficacy and safety of ZYTIGA plus prednisone compared to placebo plus prednisone, using co-primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS).  Data from this study were presented at the 48th Annual Meeting of the American Society of Clinica
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SOURCE Janssen Research & Development, LLC
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