From AVAC- FDA extends date for revview of TDF/FTC PREP

[Guest guest]

June 7, 2012Dear Advocates,This update includes information on the US Food and Drug Administration’s(FDA) review of Gilead Sciences Inc.'s application for approval of dailyoral TDF/FTC (brand name Truvada) as PrEP.Yesterday, in an email to stakeholders, Gilead communicated that the FDAhas extended by three months the target date for its review of Gilead’sapplication for a prevention indication for daily TDF/FTC. Advocates cannow expect a decision regarding approval by September 14.Gilead reported that the FDA clarified that the extension allows the agencyto complete a detailed review

of Gilead's revised Risk Evaluation andMitigation Strategy (REMS), which reflect changes discussed with the agencyafter the Advisory Committee

meeting on May 10 (details below).A REMS can include a medication guide, communication plan, educationaltraining for providers and a plan for implementation in various settings.The elements of the REMS are designed to promote safe use of a medicationaccording to its indication. Given the data to-date showing that dailyTDF/FTC is safe and effective in the context of high adherence andconfirmed HIV-negative status, it’s critical that the REMS elements be asstrong as possible.Gilead’s proposed REMS for TDF/FTC as PrEP was discussed at length at theMay 10 meeting of the FDA’s Antiviral Drugs Advisory Committee, a webcastof which is available here:http://mlist.orchidsuites.net/lists/lt.php?id=NkoBAgZbVQdeAx4FC1JdDkoBAVJUAVA%3DAt the

conclusion of that meeting the advisory committee recommended thatdaily TDF/FTC be approved for use as PrEP among HIV-negative adult men andwomen and that FDA pay close attention to the information and strategies inthe label language and the REMS.In a May 17 letter to the FDA, AVAC and over three-dozen HIV/AIDS andhealth organizations from across the US urged prompt approval of dailyTDF/FTC as PrEP along with a number of marketing and implementationrecommendations, including some modifications to the proposed REMS. AVACcontinues its strong support for an FDA approval in the near future. Wealso recognize the critical importance of taking a considered approach toall of the aspects of the dossier Gilead submitted for approval. Wecontinue to urge the FDA and Gilead to take all necessary steps to ensurethat TDF/FTC for PrEP is safe, effective and accessible to those who willneed it to reduce their risk

of HIV.If you have any questions about this development or the FDA review processoverall, please email us at avac@.... And please continue to visitPrEP Watch (prepwatch.org) for background information and updates!Best,
AVAC !! NAMASTE !!