Janssen-Cilag International has also filed a marketing authorisation application (MAA) with the European Medicines Agency for abiraterone acetate.
Abiraterone acetate was developed by Ortho Biotech Oncology Research & Development, Unit of Cougar Biotechnology.
Abiraterone acetate is an oral androgen biosynthesis inhibitor being developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies, which is also known as castration-resistant prostate cancer (CRPC).
It is believed that abiraterone works by inhibiting a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and tumour.
The application to the FDA follows the completion of randomised, double-blind, placebo-controlled Phase III study, which assessed overall survival and tolerability.
The trial evaluated patients with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to patients treated with placebo plus prednisone.
Data from this 1,195 patient study conducted in 147 centers across 13 countries were presented at the 35th Annual European Society for Medical Oncology (ESMO)Congress in October 2010.
Additional ongoing studies for abiraterone acetate are currently underway.
If approved, abiraterone acetate will be commercialised and distributed by Centocor Ortho Biotech in the US, while Janssen Pharmaceutical Companies will take up the commercialisation and distribution in all other countries around the world.