FDA panel favors Viread approval

Members of FDA's Antiviral Drug Products' Advisory Committee and invited consultants unanimously stated Wednesday that Gilead (GILD) has demonstrated that Viread tenofovir disoproxil fumarate is safe and effective for treating AIDS in treatment-experienced patients and should receive accelerated approval. The panel was divided about the company's request for a broad label indicating that Viread is safe and effective for use by all AIDS patients, including those who have not been treated with other drugs.

In GILD's pivotal Phase III trials, Viread, a nucleotide analog reverse transcriptase inhibitor, was added to stable background therapy in antiretroviral-experienced patients with relatively low plasma HIV RNA levels and high CD4 cell counts. Most committee members felt that it would be inappropriate to extrapolate from studies with pre-treated patients to treatment-naive patients. Concerns also were expressed about the lack of data in patients with high viral loads. "I have every expectation that this drug will work in treatment-naive patients, but I am concerned that the risk-benefit ratio may be different than for experienced patients and am uncomfortable [about recommending a broad indication] based on the little data we've seen," said committee Chairman Roy Gulick, associate professor of medicine at Weill Medical College of Cornell University. ...