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Vertex Says FDA Advisory Committee Recommends Approval Of Telaprevir

Vertex Pharmaceuticals Inc. (VRTX) said that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration voted to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis C. The Committee recommended by a vote of 18-0 the approval of telaprevir for those who were not treated previously and those who were treated previously but not cured with currently available medicines.

Telaprevir was studied in all major subgroups of people who were treated previously and not cured: relapsers, partial responders and null responders. The FDA is expected to make a decision on the approval of telaprevir by May 23, 2011, under the Prescription Drug User Fee Act.

Telaprevir is an investigational, oral inhibitor that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication.

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