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Centocor Ortho Biotech Submits Abiraterone Acetate NDA to FDA for Metastatic Advanced Prostate Cancer Treatment

Strategic Insights

— 1 min read

Centocor Ortho Biotech Inc, a Johnson & Johnson (NYSE: JNJ) company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the investigational drug abiraterone acetate administered with prednisone for the treatment of metastatic, advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. The company has also filed a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate.

Key Takeaways:

  • Centocor Ortho Biotech Inc has submitted a NDA to the FDA for abiraterone acetate, an investigational oral androgen biosynthesis inhibitor, for the treatment of metastatic advanced prostate cancer in patients who have received prior chemotherapy containing a taxane.
  • Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology Inc, and is being commercialized and distributed by Centocor Ortho Biotech Inc in the US and by Janssen Pharmaceutical Companies in all other countries around the world.
  • The FDA is expected to review the NDA and make a decision on the approval of abiraterone acetate for the treatment of metastatic advanced prostate cancer.
  • Janssen-Cilag International NV has also filed a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for abiraterone acetate.
  • Abiraterone acetate is believed to inhibit a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals, and tumour.

Statistics:

  • 1 NDA submitted to the FDA for abiraterone acetate.
  • 1 MAA submitted to the EMA for abiraterone acetate.
  • Abiraterone acetate is being developed for the treatment of metastatic advanced prostate cancer.
  • The drug is expected to be commercialized and distributed by Centocor Ortho Biotech Inc in the US and by Janssen Pharmaceutical Companies in all other countries around the world.

Sources:

  • M2 PHARMA - December 21, 2010 - Centocor Ortho Biotech seeks FDA nod for abiraterone acetate for metastatic advanced prostate cancer treatment.

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