Vertex Says FDA Puts Partial Hold on Hepatitis C Drug Trial
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Vertex Pharmaceuticals Inc. said U.S. regulators placed a partial clinical hold on its trial of a drug for hepatitis C after three patients receiving a high dose of the medicine showed signs of potential liver toxicity. The shares sank the most in eight months.
The Food and Drug Administration hold is on a study in the U.S. using a dose of 200 milligrams of the drug VX-135, the Cambridge, Massachusetts-based company said yesterday in a statement. The trial, in the second of three phases generally required for approval, is continuing in the 100-milligram dose.