FDA places partial hold on VX 135 for Hepatitis C
Vertex Pharmaceuticals announced that the company has received notice from the FDA that a partial clinical hold has been placed on Vertex's ongoing Phase II U.S. study of the nucleotide analogue hepatitis C virus (HCV) polymerase inhibitor VX-135.
The 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 II study in Europe. Evaluation of a 100 mg dose of VX-135 in combination with ribavirin as part of the 12-week Phase II study in the U.S. is continuing as planned.
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