Johnson & Johnson units file for new Zytiga use in USA and EU

Janssen Research & Development, a subsidiary of US drugs giant Johnson & Johnson (NYSE: JNJ), has submitted a supplemental New Drug Application to the US Food and Drug Administration for its prostate cancer drug Zytiga (abiraterone acetate) for an additional indication. Simultaneously, J&J unit Janssen-Cilag International NV has filed a type II variation to the European Medicines Agency for the drug.

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 USA 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 USA, Zytiga has been cleared for marketing in more than 45 countries.