Antiviral Drugs Advisory Committee
Committee Meeting on April 28, 2011, from 8 a.m. to 5:00 p.m.
Agenda: On April 28, 2011, the committee will discuss a new drug application (NDA) 201-917, telaprevir (a hepatitis C virus protease inhibitor), manufactured by Vertex Pharmaceuticals, Inc., with a proposed indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy. Compensated liver disease is a stage in which the liver is damaged but maintains ability to function.
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