October 27, 2010
Reuters reports that the developers of a vaginal microbicide gel containing the antiretroviral tenofovir, which has been found to reduce "HIV infections in women by 39 percent," said the FDA last week granted fast-track approval designation to the gel.
"The FDA would require more information on whether the gel works and is safe, but will help speed up the process, said Dr. Henry Gabelnick, executive director of CONRAD, one of the groups developing the gel," the news service writes (Fox, 10/27).
"With fast track designation, an NDA [New Drug Application] can be submitted as a 'rolling review', which allows a clinical trial sponsor to submit completed sections of its NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed," according to a CONRAD press release (10/25). The microbicide trial was conducted by the Center for the AIDS Program of Research in South Africa (CAPRISA) in collaboration with CONRAD and Family Health International (FHI), Reuters reports. The drug manufacturer Gilead licensed its drug tenofovir for use in the gel (10/27).
"A number of key stakeholders contributed to the collaborative meeting with the FDA, including representatives from the U.S. National Institutes of Health, the U.S. Agency for International Development, Gilead Sciences, Microbicides Trial Network (MTN), South African clinical investigators, the International Partnership for Microbicides (IPM) and FHI," the CONRAD press release states, adding that "the FDA stated their preference for two well-controlled studies to verify the safety and efficacy of 1% tenofovir gel prior to submission of a New Drug Application (NDA)" (10/25).
Gabelnick told Reuters that researchers are still working on a final report on the findings of the CAPRISA study and that a second trial called VOICE (Vaginal and Oral Interventions to Control the Epidemic), aimed at confirming the safety and effectiveness of the gel, is also underway. Additionally, researchers at the University of Pittsburgh are testing the tenofovir gel in men who have sex with men, the news service writes. "The FDA will want to see results from VOICE, due in 2013 or 2014, before considering approval of the gel," according to Reuters. "The FDA has also asked for data on how the gel works in adolescents and women past menopause," the news service reports.
The article details the benefits of a viable microbicide gel to help protect women against HIV/AIDS and efforts to come up with viable manufacturers and distribution networks for the microbicide gel (10/27).