January 9, 2013 / 5:21 PM / 5 years ago

Idenix says FDA seeks more time to review hepatitis C drug

(Reuters) - Idenix Pharmaceuticals Inc said the U.S. health regulator had informed the company that it would need more time to conduct a safety review of Idenix’s hepatitis C drug.

The company said on its website that the FDA had conveyed the need for additional time earlier this month. (r.reuters.com/jah25t)

Idenix said it submitted data to the U.S. Food and Drug Administration in December.

The FDA had placed the drug, IDX184, on a partial clinical hold last August, citing adverse cardiac events seen in rival Bristol-Myers Squibb Co’s hepatitis C drug.

Idenix cannot enroll patients in further studies until it gets FDA clearance for the trial design. The company now expects a response in the first quarter of 2013.

Shares of the Cambridge, Massachusetts-based company were down 7 percent at $4.67 on Wednesday morning on the Nasdaq.

Reporting by Pallavi Ail in Bangalore; Editing by Roshni Menon

Our Standards:The Thomson Reuters Trust Principles.
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