FDA places clinical hold on Achillion's hepatitis C drug
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.
- Children's corpses reveal desperate attempts to escape Korean ferry |
- Russia says it will respond if Ukraine interests attacked |
- Vote delayed on loan guarantee for World Trade Center developer
- Obama seeks to ease Asian allies' doubts during visit to Japan |
- NYPD Twitter campaign backfires, thousands of negative tweets