FDA held advisory committee hearing on alternate use of drug May 10th; a decision on Gilead’s application was expected as soon as next Friday, June 15th
In mid-February, FDA granted an expedited review of Gilead’s supplemental New Drug Application (sNDA) for use of Truvada as an HIV prevention pill—an announcement that came despite dubious research studies and days after release of another study that showed one key component of Truvada is associated with significant risk of kidney damage and disease that increases over time
WASHINGTON (June 8, 2012) AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider welcomed the news today that the Food and Drug Administration (FDA) is delaying a ruling on and application by Gilead Sciences for the possible approval of the use of its blockbuster AIDS treatment Truvada as a form of HIV prevention pill. Gilead filed a supplemental new drug application (sNDA) for such use in December; in February 2012, the FDA granted an expedited review of Gilead’s application for approval by the FDA to market once-daily Truvada® (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV in uninfected adults. On May 10th, the FDA held an Advisory Committee hearing on the issue during which public comment opposing such use of the drug was heard from by more than 25 members of the audience. At the conclusion of the meeting, the Advisory Committee voted to advise the FDA to grant approval of Gilead’s application. Under statutory regulations, it was expected that a ruling by the FDA would be issued by next Friday, June 15th.
“We are extremely pleased that the FDA will delay a decision on approval of use of Gilead’s AIDS treatment Truvada as a form of HIV prevention and will take another look at the issue and process,” said Michael Weinstein, AHF’s President. “From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support—as well as other studies in which were stopped outright as they were showing no preventive benefit whatsoever. If the FDA ultimately goes forward with an approval of the drug for prevention use, at minimum they should require HIV testing as part of the protocol—something the advisory committee decided against when it recommended approving use of Truvada as prevention.”
With respect to Gilead’s supplemental new drug application for Truvada as a prevention pill, it is AHF’s understanding that many members of the Antiviral Drugs Advisory Committee had taken firm positions regarding the desirability of approving the sNDA long before the committee met in May. The fact that a majority of the committee (it is believed that the committee comprised 23 voting members on May 10, 2012) had been appointed less than one month before the meeting, and that at least eight members were appointed within one week of the meeting, suggests that committee members were not properly vetted and screened regarding possible intellectual conflicts of interest.