Idenix Anticipates Delay in Testing of Hepatitis C Drug, FDA Needs More Data

Idenix Pharmaceuticals Inc issued a press release announcing a possible delay on the human trials of a hepatitis C drugs so they can provide additional safety data that the U.S. Food and Drug Administration seeks from them.

The biopharmaceutical company confirmed that they will need to postpone all the clinical trials of the drug they call IDX20963 until FDA gives them a go signal.

This is the third issue between Idenix and FDA as recently this year, the company halted IDX184 and IDX19368 which are both hepatitis C drugs too. FDA had to stop them after a patient died during the mid-stage trial compromising the safety of the procedures of another company Bristol-Myers Squibb Co. The agency wants to ensure that such incident will not recur on other clinical trials.

The developers of the hepatitis C drugs were using a technology called polymerase inhibitors, or nucs. Nucss stop the spread of a virus and became a new class of drugs which can combat hepatitis C. IDX20963 is made from nucs that are different from what Bristol used. However, FDA remained strict about their safety requirements.

This incident affected even the stock value of Idenix as its shares went down at $4.03 and closed at $5.13 in Nasdaq on Thursday.

Hepatitis C is a contagious disease that targets the liver which can last for weeks to a lifetime. Complications may result to liver failure and liver cancer. Most of the people were infected by the hepatitis C virus through needle sharing when injecting drugs, blood transfusions, and even organ transplants. The Centers for Disease Control and Prevention recorded about 16,000 acute cases in 2009 and 3.2 million cases of chronic hepatitis C. Most of the people were not aware that they were infected because they don’t look and feel sick.

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