FDA receives additional marketing application for Janssen ZYTIGA
Janssen Research & Development has announced that it has submitted a supplemental New Drug Application to FDA for ZYTIGA(abiraterone acetate).
Janssen-Cilag International NV has also sent a type II variation to the European Medicines Agency (EMA) for approval.
The two applications are intended to increase the uses of ZYTIGA administered with prednisone to include the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Since its first approval in the U.S. in 2011, ZYTIGA has got approval in more than 45 countries. The filing of sNDA was completed by Janssen Research & Development on behalf of Janssen Biotech.
ZYTIGA Vice President Michael L. Meyers said,"We're delighted to move forward so quickly with these regulatory submissions, building on the momentum created by the data presentation two weeks ago."
"We look forward to working with the FDA and EMA to make ZYTIGA available for men with metastatic prostate cancer earlier in the course of their disease," Michael added.