FDA says Roche cancels heart transplant study

Thu Feb 22, 2007 5:14pm EST
 
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WASHINGTON (Reuters) - Roche Holding AG had ended its study of heart transplant patients after a higher than expected rate of acute organ rejection was found, U.S. health regulators said on Thursday.

The FDA said patients in the trial were switched from a regimen of calcineurin inhibitor and the company's immunosupressant drug CellCept to the immunosupressant drug sirolimus and CellCept.

Sirolimus is sold by Wyeth under the brand name Rapamune.

 
Dr. Qurrath U. Ain of the Elmhurst Pediatric Emergency Center examines a patient with flu-like symptoms at Elmhurst Hospital in New York in this December 12, 2003. file photo. REUTERS/Shannon Stapleton/Files
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