Anti HIV drug Tenofovir in its gel form is to be fast-tracked for approval by the US FDA. The announcement was made by Conrad, a nonprofit scientific organization based in Arlington, Virginia that works with reproductive health.
Tenofovir gel has shown promise in prevention of HIV transmission. This July researchers at the XVIII International AIDS Conference (IAC) in Vienna reported that a 1 percent tenofovir vaginal gel cut male-to-female HIV transmission by 39 percent, and herpes infections by 51 percent. The results were seen in the Centre for the AIDS Programme of Research in South Africa (CAPRISA 004) study and further studies were advocated. The question was to make the drug available fast.
As an answer to the availability question Conrad, along with other key stakeholders, met with the FDA on October 20 for an “end of Phase II” meeting to chart the course for the ultimate approval of the gel. During the meeting, the FDA confirmed that a currently ongoing trial, called VOICES, would be sufficient in combination with the CAPRISA 004 results, Conrad to file a new drug application (NDA) for FDA approval. However similar approval needs to be sought for in other nations before they can use the drug in its gel form.
According to Professor Salim Abdool Karim, director of CAPRISA and pro vice-chancellor for research at the University of KwaZulu-Natal in Durban, “It’s a very important step… In a way, it represents that we’re half-way over the regulation hurdle when you’ve already got a lot of clarity from the regulator about what is required.” He added that the second study VOICE is also well underway saying, “The VOICE study […] is looking at whether the [tenofovir] tablets could be just as effective, or more effective or less effective than the gel.”
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