updated 1/9/2013 12:12:22 PM ET 2013-01-09T17:12:22

(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.

  1. Don't miss these Health stories
    1. Splash News
      More women opting for preventive mastectomy - but should they be?

      Rates of women who are opting for preventive mastectomies, such as Angeline Jolie, have increased by an estimated 50 percent in recent years, experts say. But many doctors are puzzled because the operation doesn't carry a 100 percent guarantee, it's major surgery -- and women have other options, from a once-a-day pill to careful monitoring.

    2. Larry Page's damaged vocal cords: Treatment comes with trade-offs
    3. Report questioning salt guidelines riles heart experts
    4. CDC: 2012 was deadliest year for West Nile in US
    5. What stresses moms most? Themselves, survey says

The company said on its website that the FDA had conveyed the need for additional time earlier this month. (http://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)

(c) Copyright Thomson Reuters 2013. Check for restrictions at: http://about.reuters.com/fulllegal.asp

Discuss:

Discussion comments

,

Most active discussions

  1. votes comments
  2. votes comments
  3. votes comments
  4. votes comments
  1. Jump to text

    (Reuters) - Idenix Pharmaceuticals Inc said the ...

  2. Jump to discussion

    Idenix says FDA seeks more time to review hepati...