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News
8 Sep 2011

EU Approves Marketing Authorisation for Zytiga

The approval comes after an accelerated regulatory review process by the European Medicines Agency (EMA) and a positive CHMP opinion.

The European Commission has approved the marketing authorisation for Janssen-Cilag International’s Zytiga (abiraterone acetate), a novel, once-daily, oral androgen biosynthesis inhibitor.

 

The approval comes after an accelerated regulatory review process by the European Medicines Agency (EMA) and a positive CHMP opinion.

 

Abiraterone acetate is approved, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

 

Abiraterone acetate is an androgen biosynthesis inhibitor that inhibits the CYP17 enzyme complex that is required for the production of androge

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