FDA advisory hearing supports approval of tenofovir/FTC for PrEP

On 10 May 2012, US FDA Antiviral Drugs Advisory Committee held an open meeting to decide on recommendations for approval for tenofovir/FTC (Truvada) to have an indication for use as Pre-Exposure Prophylaxis (PrEP) to reduce the risk of HIV transmission.

The meeting lasted more than 12 hours, and involved the panel voting on key questions.

This included a 19:3 vote in favour of recommending approval for men who have sex with men (MSM) at risk for HIV; and a vote of 19:2 (with one abstention) for recommending approval for HIV negative partners in relationships with HIV positive partners. The vote was closer for a general use to reduce sexual transmission with 12:8 in favour (with 2 abstentions).

While the FDA are not mandated to follow the panel recommendations, it is unusual for this not to happen. The final approval decision is expected by 15 June.

As part of this process, the FDA publish a briefing document prior to each advisory panel meeting, available in PDF format online, which compiles a review of the data.

Links and further information:

FDA briefing document (PDF)

Links to other websites are current at date of posting but not maintained.