A coalition of major national HIV/AIDS advocacy groups is asking that the FDA approve the Gilead drug Truvada as a daily preventive or “pre-exposure prophylaxis” (PreP) against infection. Among the groups joining the demand are amfAR and the San Francisco AIDS Foundation. Via press release:
The PrEP sNDA for Truvada®meets criteria set out in FDA’s Manual of Policies and Procedures for priority review. As organizations committed to ending the AIDS epidemic, we appreciate how the history of FDA’s regulatory tools for fast track approval or for accelerated and priority review introduced the current suite of HIV therapeutic drugs to treat active infection. In the present case, there is a clear unmet need for new effective methods for preventing HIV infection, a need that is as urgent today as was the need for HIV therapeutics over the past two and more decades.
The press release notes the “unfortunate” opposition to PreP therapy voiced by the controversial AIDS Healthcare Foundation, which contends that the long-term effects of Truvada on the non-infected have not been fully examined. AHF has been vigorously lobbying to block the FDA from making the above-requested classification change.