FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C (VRTX)

Vertex Pharmaceuticals Incorporated VRTX today announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration voted unanimously 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. The FDA is not bound by the Committee's recommendation, but usually follows its advice.