ARTICLE | Product Development
Paradigm shift in AIDS
September 10, 2007 7:00 AM UTC
Perhaps because there is no controversy or hint of scandal associated with the product, an FDA advisory committee's unanimous endorsement last week of Isentress raltegravir from Merck & Co. Inc. barely registered on media radar screens. But the Antiviral Drugs Advisory Committee meeting sets the stage for the second first-in-class HIV therapy approval in 2007 and what will likely be a paradigm shift in AIDS treatment.
Isentress, which has a mid-October PDUFA date, would be the first marketed integrase inhibitor...