June 7, 2012
This update includes information on the US Food and Drug Administration’s (FDA) review of Gilead Sciences Inc.'s application for approval of daily oral TDF/FTC (brand name Truvada) as PrEP.
Yesterday, in an email to stakeholders, Gilead communicated that the FDA has extended by three months the target date for its review of Gilead’s application for a prevention indication for daily TDF/FTC. Advocates can now expect a decision regarding approval by September 14.
Gilead reported that the FDA clarified that the extension allows the agency to complete a detailed review of Gilead's revised Risk Evaluation and Mitigation Strategy (REMS), which reflect changes discussed with the agency after the Advisory Committee meeting on May 10 (details below).
A REMS can include a medication guide, communication plan, educational training for providers and a plan for implementation in various settings. The elements of the REMS are designed to promote safe use of a medication according to its indication. Given the data to-date showing that daily TDF/FTC is safe and effective in the context of high adherence and confirmed HIV-negative status, it’s critical that the REMS elements be as strong as possible.
Gilead’s proposed REMS for TDF/FTC as PrEP was discussed at length at the May 10 meeting of the FDA’s Antiviral Drugs Advisory Committee, a webcast of which is available here. At the conclusion of that meeting the advisory committee recommended that daily TDF/FTC be approved for use as PrEP among HIV-negative adult men and women and that FDA pay close attention to the information and strategies in the label language and the REMS.
In a May 17 letter to the FDA, AVAC and over three-dozen HIV/AIDS and health organizations from across the US urged prompt approval of daily TDF/FTC as PrEP along with a number of marketing and implementation recommendations, including some modifications to the proposed REMS. AVAC continues its strong support for an FDA approval in the near future. We also recognize the critical importance of taking a considered approach to all of the aspects of the dossier Gilead submitted for approval. We continue to urge the FDA and Gilead to take all necessary steps to ensure that TDF/FTC for PrEP is safe, effective and accessible to those who will need it to reduce their risk of HIV.
If you have any questions about this development or the FDA review process overall, please don’t hesitate to be in touch. And please continue to visit PrEP Watch for background information and updates!