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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