July 1 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.