Applications for the approval of Abiraterone Acetate (Abiraterone) have been submitted to both the U.S. Food and Drug Administration (FDA) and to the European Medicines Agency (EMA).

The applications are for the approval of Abiraterone with prednisone for the treatment of metastatic advanced prostate cancer in men who have received prior chemotherapy containing a taxane.

Abiraterone is an investigational oral androgen biosynthesis inhibitor developed for the treatment of metastatic advanced prostate cancer that has developed resistance to conventional hormonal therapies (castrate resistant). It is believed that abiraterone acetate inhibits a key enzyme, CYP17, needed for androgen biosynthesis in the testes, adrenals and in the tumor.

Both applications follow completion of a Phase 3, randomized, double-blind, placebo-controlled clinical study (COU-AA-301) of 1,195 men, which evaluated overall survival and tolerability in men with metastatic advanced prostate cancer treated with abiraterone acetate plus prednisone compared to treatment with placebo plus prednisone. The study was conducted in 147 centers in 13 countries. In September 2010, the study was unblinded on the recommendation of an Independent Data Monitoring Committee since the results were overwhelming positive.

There are Additional ongoing studies currently underway for abiraterone acetate.

“These regulatory file submissions are an important milestone for men with metastatic advanced prostate cancer and for our company,” said William N. Hait, M.D., Ph.D., Global Therapeutic Head, Oncology, Johnson & Johnson Pharmaceutical Research & Development, LLC. “We believe that we can develop important therapies to treat devastating diseases by focusing on the tumor micro-environment. Abiraterone acetate is a key part of this strategy, and we look forward to working with health authorities to provide a new therapeutic option for metastatic advanced prostate cancer patients.”

If approved, abiraterone acetate will be commercialized and distributed by Centocor Ortho Biotech Inc. in the U.S. and by Janssen Pharmaceutical Companies in all other countries around the world.

Now we wait for the reviews from both the FDA and the EMA. They are both being fast tracked, so hopefully we will see an approval in calendar year 2011.

Joel T Nowak, M.A., M.S.W.