The FDA gave its final blessing to preventive use of Gilead Sciences' ($GILD) HIV drug Truvada. The move was expected, after the agency's advisory panel voted to back the new indication. And it won't move the needle much on Gilead's Truvada sales.
But the approval was rightly hailed as historic. It's the first time an HIV drug has been approved to stave off HIV infection, rather than treat those who've already caught the virus. "The hope is that over time it will decrease the rate of new infections," FDA's Debra Birnkrant told The Wall Street Journal.
Depending upon the point of view, however, the FDA nod is either historically prescient, a watershed moment in the fight against AIDS. Or, it's historically "reckless," as the AIDS Healthcare Foundation told the WSJ.
FDA's approval requires cautionary language on Truvada's label: To qualify for preventive use, patients should be tested for HIV first, to make sure they're not already infected. They should also be monitored every three months after that. The measures are designed to stave off growing resistance to the drug.
But opponents say those precautions aren't enough. "If it's that important, why isn't it a requirement?" the foundation's Michael Weinstein said.
- read the WSJ piece
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