Gilead Submits Application to FDA Asking for PrEP Approval for Truvada
December 16, 2011
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).
HIV PJA Strategy Webinar Recap: FEM-PrEP Trial Closure, U.S. Pricing & Access Issues After iPrEx, & UN Update
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily Global Health Policy Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read TheBody.com's Comment Policy.)