Viread approval recommended
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
At Oct. 3 meeting, FDA's Antiviral Drugs Advisory Committee unanimously recommends use of Gilead's antiviral Viread (tenofovir disoproxil fumarate) in adult patients with HIV infection who have received prior antiretroviral therapy. Due to a lack of data in treatment-naive patients and other concerns, a majority of committee members favored restricting use to treatment-experienced patients. Gilead is conducting a 601-patient Phase III trial in treatment-naive subjects, and analysis of results should be completed in the first half of 2002