CAMBRIDGE (MASSACHUSETTS) (dpa-AFX) - Vertex Pharmaceuticals Inc. (VRTX) announced that the U.S. Food and Drug Administration has placed a partial clinical hold on its ongoing Phase 2 U.S. study of the nucleotide analogue hepatitis C virus polymerase inhibitor VX-135.
This partial clinical hold prevents evaluation of a 200 mg dose of VX-135 in the U.S. study following observation of reversible elevated liver enzymes in patients receiving 400 mg of VX-135 in combination with ribavirin in a Phase 2 study in Europe.
Meanwhile, the company said evaluation of a 100 mg dose of VX-135 in combination with ribavirin as part of the 12-week Phase 2 study in the U.S. is continuing as planned.
The company's stock, which closed Thursday's session at $87.62, declined over 8 percent to $80.00.
The company said it is committed to continuing to work closely with the FDA to provide the data needed to support evaluation of a 200 mg dose of VX-135 in the U.S.
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