Merck Isentress advisory committee
Executive Summary
Merck's HIV integrase inhibitor Isentress (raltegravir) will be the second potentially first-in-class HIV drug to be reviewed by FDA's Antiviral Drugs Advisory Committee in 2007. The panel will meet Sept. 5 to discuss Merck's treatment claim for use in combination with other antiretroviral agents in treatment-experienced patients with evidence of viral replication despite ongoing therapy. The panel's first meeting of 2007 was held in April to review Pfizer's CCR5 antagonist maraviroc (1"The Pink Sheet" April 30, 2007, p. 24). The committee will meet in closed session Sept. 6...