FDA Delaying Decision on Gilead’s Truvada sNDA for HIV Prevention

The FDA has informed Gilead Sciences it needs at least three more months to weigh its Truvada sNDA for HIV prevention, AIDS advocates say. Gilead broke the news late Wednesday in a letter to stakeholders, including the New York-based AIDS Vaccine Advocacy Coalition (AVAC), saying the decision date on the sNDA has been pushed back to Sept. 14 to allow for a more detailed agency review of Gilead’s proposed risk evaluation and mitigation strategy (REMS). An FDA ruling had been expected by Friday.
Drug Industry Daily