J&J's (JNJ) Janssen-Cilag Submits Additional Marketing Application for ZYTIGA
Tweet Send to a FriendGet Alerts JNJ Hot Sheet
Price: $86.82 -0.45%
Overall Analyst Rating:
NEUTRAL (= Flat)
Dividend Yield: 3%
Revenue Growth %: +8.7%
Overall Analyst Rating:
NEUTRAL (= Flat)
Dividend Yield: 3%
Revenue Growth %: +8.7%
Trade JNJ Now!
Johnson & Johnson's (NYSE: JNJ) Janssen-Cilag International NV announced today it has submitted a type II variation to the European Medicines Agency (EMA) for ZYTIGA ^® ; simultaneously, Janssen Research & Development, LLC submitted a supplemental New Drug Application (sNDA) to the U.S. FDA; Both applications are intended to extend the use of ZYTIGA administered with prednisone for 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.
Both regulatory applications follow the announcement of results observed from pre-specified interim analyses of the international Phase 3, randomized, double-blind, placebo-controlled COU-AA-302 clinical study. This study, which included 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy, evaluated the effect of ZYTIGA plus prednisone on the co-primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) compared to placebo plus prednisone. Data from this study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) earlier this month.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
Both regulatory applications follow the announcement of results observed from pre-specified interim analyses of the international Phase 3, randomized, double-blind, placebo-controlled COU-AA-302 clinical study. This study, which included 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy, evaluated the effect of ZYTIGA plus prednisone on the co-primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) compared to placebo plus prednisone. Data from this study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) earlier this month.
Join StreetInsider.com FREE and get immediately alerted when news breaks on your stocks and other market items - JOIN NOW
*NEW - Download StreetInsider's FREE iPhone and iPad App - Click Here
You May Also Be Interested In
- Janssen Pharma (JNJ) Plans Slew of Filing, Extension Submissions by FY17
- A.G. Lafley Returns as President/CEO of Procter & Gamble (PG)
- News Corp (NWSA) Splits In Two; Announces $500M Buyback Plan
Create E-mail Alert Related Categories
Corporate News
Login with Facebook
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
