Gilead's Truvada has won historic FDA approval as the first drug ever to prevent sexually acquired HIV infection in healthy adults, Reuters reports.
It's a big victory for lawyers who worked to get Gilead's Truvada approved -- though their work is likely far from over.
Monday's FDA approval comes two years after groundbreaking reports that Truvada reduced the risk of HIV infection in the high-risk group of men who have sex with men. A separate study found even better results among heterosexual couples.
But the FDA's approval also comes with some conditions.
Gilead's Truvada researchers must collect samples and data from anyone who takes the drug and yet still becomes infected with HIV, according to Reuters. That's to help learn about any potential resistance to the drug.
Similarly, Gilead must also collect data on the outcomes of pregnancies by women who take Truvada.
Monday's Truvada approval marked the end of the FDA's complicated drug approval process. In general, the process involves:
- Lab and animal tests, the results of which a company must submit as part of an Investigational New Drug application prior to tests in humans.
- Human drug trials in three phases, monitored by the FDA.
- A balancing test, to make sure the drug's benefits outweigh its risks before it is approved.
Though Gilead's Truvada has been approved as the world's first HIV-prevention drug, its lawyers are likely still at work. The FDA is expected to decide in September whether to grant Truvada marketing clearance as a form of HIV prevention, and the World Health Organization is working on international guidelines for the use of Truvada, Bloomberg News reports.
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