FDA places clinical hold on Achillion's hepatitis C drug

July 1 Mon Jul 1, 2013 4:30pm EDT

July 1 (Reuters) - Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration had placed a clinical hold on its hepatitis C drug sovaprevir after elevations in liver enzymes were noted in an early-stage study of the drug's interaction with an HIV drug.

The company said the FDA had asked for study reports from two drug-drug interaction studies involving the drug and a safety analysis of ongoing trials.

The FDA issues clinical holds to delay the clinical investigation of a drug, or to suspend an ongoing investigation. Companies may not recruit new subjects when an ongoing study is placed on a clinical hold.

The company said it expected to provide the information to the FDA within about six weeks.

Shares of the company, which were halted prior to the news, closed at $8.36 on Monday on the Nasdaq.

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Comments (1)
MKDuke wrote:
Tylenol raises the liver enzymes also, yet we don’t see it being held back. Most people do not even know it raises the enzymes and with long time serious use may cause liver damage.

Jul 01, 2013 10:33pm EDT  --  Report as abuse
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