Janssen Research and Development (06/15/12)
Janssen Research & Development has announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for ZYTIGA (abiraterone acetate), while Janssen-Cilag International NV has announced the submission of a type II variation to the European Medicines Agency. These 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 originally approved in the U.S. 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. The regulatory applications were made following the announcement of results observed from pre-specified interim analyses of the COU-AA-302 clinical study, which evaluated the efficacy and safety of ZYTIGA plus prednisone compared to placebo plus prednisone, using co-primary endpoints of radiographic progression-free survival and overall survival. The most common adverse reactions included arrhythmia, cough, diarrhea, dyspepsia, edema, fractures, hot flush, hypertension, hypokalemia, joint swelling or discomfort, muscle discomfort, nocturia, upper respiratory tract infection, urinary frequency, and urinary tract infection.