Gilead Submits Application to FDA Asking for PrEP Approval for Truvada

Pharmaceutical company Gilead Sciences on Thursday submitted an application to the FDA asking the agency to approve its antiretroviral drug Truvada for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among adults, a Gilead press release reports. "If the [application] is approved, Truvada would be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex," the press release notes (12/15).

Several international studies of the drug have shown it can reduce the risk of HIV infection among adults, according to the San Jose Mercury News. "It remains uncertain how the FDA will respond to the request, and reviews of drug applications can take years," the newspaper writes (Johnson, 12/15). The press release notes that "CDC is currently developing formal U.S. Public Health Service guidelines for the use of PrEP" (12/15).