An FDA advisory panel today is expected to recommend approval of Viread (tenofovir disoproxil fumarate) tablets, Gilead Sciences Inc.¿s proposed treatment for HIV.
The Antiviral Drugs Advisory Committee of the Center for Drug Evaluation and Research will hear Gilead¿s application today. The FDA¿s briefing document released Tuesday said the safety and efficacy data support Gilead¿s results and conclusions. ¿This NDA provides clear evidence of tenofovir¿s antiviral activity (over 24 weeks) when added to a stable background regimen,¿ the document said.
Viread, a once-daily tablet, is a nucleotide reverse transcriptase inhibitor that can be administered in conjunction with other HIV drugs. (See BioWorld Today, Sept. 26, 2001.)
Gordon Cohen, an associate with Banc of America Securities in New York, said Viread should generate about $400 million in worldwide sales at its peak. ¿ Kim Coghill