September 7, 2010

FDA Puts Hold on Idenix Study Due to Safety Concerns

By Jennifer Booton
Published September 07, 2010

Idenix Pharmaceuticals (NASDAQ:IDIX) tumbled nearly 50% Tuesday on news that safety concerns led to the suspension by the US Food and Drug Administration of a drug interaction study involving a treatment for Hepatitis C.

The decision emerged after Idenix notified the FDA of three serious adverse events related to liver function that occurred during a drug-to-drug interaction study of the combination of IDX184 and IDX320 in healthy volunteers.

The liver function tests have since returned to normal, the company said, and no healthy volunteers or patients are currently receiving the treatment.

“We will work closely with independent experts and our external safety committee to better understand the cause of these serious adverse events in the combination study of IDX184 and IDX320 and to provide the FDA with more information in order to expedite their review and resolve this matter as quickly as possible,” CEO Jean-Pierre Sommadossi, Ph.D. said.

Based on the studies, he said, the company remains committed to the “future potential” of the drugs.


No comments:

Post a Comment