Published May 11, 2012
A committee of the Food and Drug Administration has given the nod to Gilead Sciences’ (GILD) Truvada drug to help stop the onslaught of HIV infection, putting the pill on a fast-track for marketing approval in the U.S.
Thursday night’s approval by the Antiviral Drugs Advisory Committee is important because the FDA historically follows the recommendations of its panels. The FDA will review Gilead’s supplemental drug application, first submitted last December, over the next six months.
The once-daily oral drug is being explored to reduce the risk of HIV-1 infection among unaffected adults. If approved, it would be the first agent indicated for uninfected people to lower their risk of acquiring the sexually-transmitted disease.
Committee members voted 19 to 3 in favor of approval for Truvada to be used in a prevention strategy known as pre-exposure prophylaxis, or PrEP, in men who have sex with other men. It supported the drug 12 to 8 in both men and women at risk of acquiring HIV through sexual activity.
The green light came amid several late-stage and other clinical trials that showed Truvada helped reduce HIV risk.
In 2004, the FDA approved Truvada for the treatment of HIV-1 infection, making it today’s most-prescribed antiretroviral treatment in the U.S., Gilead said.