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. (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)

Source: http://news.yahoo.com/idenix-says-fda-seeks-more-time-review-hepatitis-171223741.html

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