FDA posts Viread data

FDA is satisfied that Viread tenofovir disoproxil fumarate from Gilead (GILD) is safe and effective to treat AIDS patients taking antiretroviral drugs, but the agency is concerned that the company may not have sufficient data to support a broad indication, according to data that will be presented to an advisory committee on Wednesday. FDA's report to the Antiviral Drug Products' Advisory Committee states that GILD's NDA "provides clear evidence of tenofovir's antiviral activity (over 24 weeks) when added to a stable background regimen. In two pivotal studies statistically significant reductions in HIV RNA were observed in antiretroviral-experienced patients." GILD is seeking accelerated approval for use of Viread "in combination with other antiretroviral agents for the treatment of HIV infection in adults," but FDA expressed concern that the compound has not been studied in treatment-naive patients.

GILD's Viread trials involved the addition of Viread, a nucleotide analog reverse transcriptase inhibitor, to stable background therapy in antiretroviral-experienced patients with relatively low plasma HIV RNA levels and high CD4 cell counts. FDA said the "results are noteworthy given that the majority of approvals have been based primarily on studies in treatment-naive patients." ...