August 29, 2012 / 1:35 PM / 7 years ago

J&J's Zytiga to be reviewed faster by FDA for additional use

(Reuters) - Johnson & Johnson said an application to gain approval for a new usage of its prostate cancer treatment Zytiga won a priority review status from U.S. health regulators, meaning that the drug would be reviewed faster than usual.

The company is trying to get Zytiga approved to treat prostate cancer patients who have not undergone chemotherapy. The drug gained U.S. approval in 2011 to treat prostate cancer patients who have previously received chemotherapy.

The priority review status, which is granted by the FDA to expedite the review of drugs to treat serious diseases and fill unmet medical needs, means that the drug would be reviewed in six months rather than the usual 10 to 12-months.

Zytiga’s worldwide sales rose about $32 million sequentially to $232 million in the second quarter.

The company said it had submitted the application in June.

(The first paragraph of this story has been corrected to say treatment, not cure)

Reporting by Zeba Siddiqui in Bangalore; Editing by Akshay Lodaya

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below