The U.S. Food and Drug Administration has extended its review of Gilead Sciences’ approval application for Truvada (tenofovir plus emtricitabine) as pre-exposure prophylaxis (PrEP), according to a June 6 announcement by the company. Whereas an approval decision was originally expected by this Friday, June 15, the agency now has until September 14 to make its final determination.
“The FDA has indicated that this extension relates to the agency’s standard administrative procedures for reviewing Gilead’s proposed Risk Evaluation and Mitigation Strategy (REMS) for Truvada as PrEP,” Gilead’s Gregg Alton specified in the announcement sent to HIV treatment and prevention advocates. “As was discussed at the FDA Advisory Committee Meeting last month, there are many components of a REMS, including a Medication Guide, educational training and an implementation system, all of which may require additional time for adequate FDA review.”