HIV Prevention Drug Receives FDA Panel’s Backing
The drug has already been approved as a treatment for HIV/AIDS. The FDA is expected to decide about approval by June 15.
The Associated Press: FDA Panel Backs First Pill To Block HIV Infection
The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS. In a series of votes, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner (Perrone, 5/10).
Politico Pro: Panel Backs First HIV Prevention Drug
The drug is already approved as an HIV/AIDS treatment, but giving it approval for prevention has been controversial. AIDS advocacy groups had split about whether it would save lives — or cause people to engage in risky behavior because they overestimate the drug's protective effect (Millman and Norman, 5/10).
Bloomberg: Gilead's Pill Winds U.S. Panel Backing To Prevent HIV
The panel of doctors, researchers and patients voted that [Gilead Sciences Inc. (GILD)'s HIV drug] Truvada, currently marketed to treat those infected with HIV, is safe and effective as a form of prevention in high-risk individuals, including gay men whose partners have the disease. The Food and Drug Administration is expected to decide by June 15 and doesn't have to follow the panel's recommendation (Pettypiece and Flinn, 5/11).