FDA Panel to Vote on AIDS Drug

Today, a Food and Drug Administration (FDA) advisory panel will vote on whether to recommend approval of an AIDS drug for patients who have become resistant to other medicines. If the vote is favorable, as is expected, the FDA will also decide whether the new treatment will be a last-resort drug or one sanctioned for use in early stages of the disease.

The FDA usually follows the advice of its advisory committee, making the vote today one that may lift the last hurdle facing Gilead Sciences' AIDS drug Viread. Trading in Gilead shares was halted yesterday after the FDA posted a staff report so favorable that it suggested the real question was whether the drug would be a last resort or first-line AIDS treatment. Gilead hopes to have Viread on the market in November.

"We're asking that it be labeled for all HIV infections," said Carol Brosgart, Gilead's vice president for clinical affairs. In support of Gilead, San Francisco's Project Inform's Martin Delaney said, "I'll be damned if we sit there and let them produce a narrow-label indication. This may well be the least toxic AIDS drug yet studied."

In its largest study to date, Gilead tested Viread on HIV-positive patients who had been taking other AIDS drugs for at least five years. A majority of these patients were beginning to develop resistance to the medications. Their viral load was increasing and their CD-4 cell counts were declining, signs of immune system failure. The FDA staff report leaves little doubt that Viread reduced viral load by about 75 percent. Gilead's testing "provides clear evidence of [Viread's] antiviral activity," the report said.

The FDA is expected to make a final decision on Viread by Nov. 1. If it decides that Viread should only be used as a last resort, Gilead is prepared to submit new studies to support its case for early use.

Back to other CDC news for October 3, 2001

Previous Updates