The anti-HIV drug Truvada may be approved by the FDA.
May 11, 2012- A FDA panel said it supported the first medication that is shown to prevent being infected by HIV. The panel of advisers backed the pill, which helped cleared the way for its possible landmark approval in the three-decade fight against HIV, which causes AIDS.
The Food and Drug Administration panel said they recommended the pill’s approval. Truvada is designed for healthy individuals who might be at high risk of becoming infected with HIV, including homosexual and bisexual males and heterosexual couples that have one partner who is HIV-positive.
The panel’s advice is not mandatory and the FDA does not have to follow suit, although it usually does. A final FDA decision is due to come on or before June 15. Truvada has been marketed by Gilead Sciences Inc. since 2004 for treating people who have already been infected with HIV. The drug is a mix of two previous HIV medications Viread and Emtriva. It is usually prescribed by doctors as part of a “cocktail” of drugs to repress HIV.
The panelists backed the drug for prevention, but the 12-hour discussion highlighted many concerns that were created by the drug. The panel discussed whether Truvada could lead to a decrease in condom use, which is the best defense against being infected by the virus. In addition, the panel questioned the effectiveness of the drug in women, who showed substantially lower rates of being protected in previous studies.
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