FDA Halts Testing of Idenix Drug for Hepatitis

On Friday, Idenix Pharmaceuticals Inc. announced that its hepatitis C drug candidate was pulled from consideration by federal regulators. The firm said clinical trials of valopicitabine were stopped when the Food and Drug Administration reported it thought gastrointestinal side effects, such as vomiting and nausea, offset the drug's benefits.

During valopicitabine trials, the pill was paired with interferon and ribavirin. Side effects seen in early testing led researchers to decrease valopicitabine's dosage from 800 mg to 200 mg.

"I think many people have been saying that it is questionable that this drug should be further developed," said Howard Liang, a biotechnology analyst for Boston-based Leerink Swann & Co. "I think the FDA made the decision for them."

Idenix will discuss future plans for valopicitabine with its partner, Novartis AG, said Teri Dahlman, an Idenix spokesperson. "We're considering all options."

There is a great need for orally administered hepatitis drugs, as well as for drugs that cause fewer side effects, said Raymond Chung, director of hepatology at Massachusetts General Hospital. "The therapy involved has difficulty being tolerated by many patients," he said, and it has about a 54 percent cure rate.
" A year of their life could be diminished by having to go through the therapy," Chung said.

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