In July, reports of a successful anti-HIV vaginal gel wowed the the International AIDS Conference in Vienna. Now the US Food and Drug Administration is looking to speed the gel’s approval, according to the drug’s makers, who met with the agency last week.
Henry Gabelnick, the executive director of CONRAD, one of the groups developing the tenofovir gel, told Reuters that the gel has been fast-tracked, meaning that data can be submitted as it becomes available.
Results from the first study, involving 889 South African women, showed that the group of women using the gel had an infection rate 39% lower than the placebo group. And among women who used the gel most consistently, the rate of infection was lowered by 54%. But the FDA will want to see results from the VOICE trial, expected to conclude in 2013 or 2014, before seriously considering the gel for approval.