FDA Panelists Have Voted for the Approval of Truvada to Prevent HIV
The Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted for the approval of Truvada, a Gilead Sciences HIV preventing drug after a 12-hour meeting.
Truvada is made up of emtricitabine and tenofovir disoproxil fumarate, and has been voted to be approved for once-daily oral administration to reduce the risk of HIV-1 infection in healthy people i.e. pre-exposure prophylaxis or PrEP.
After the approval of Truvada, it would be the first drug in 30 years to be approved for HIV before the infection. It was approved by FDA in 2004 for HIV-1 infection treatment. It has not been indicated for HIV prevention, but is one of the most prescribed antiretroviral treatments in U.S. It came into news in 2010, when researchers found that it can be used to prevent HIV infection.
"The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine," said Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug. "I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits."
Some of the members have also voted against the drugs approval, such as Dr. Lauren Wood of the National Cancer Institute, who believes that the drug related renal problems have not been addressed in black people. "I don't think that is adequate when you're talking about the population that is most at risk," she said.
Gilead Sciences has reported, The recommendations of the Advisory Committee are not binding, but will be considered by the FDA as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.