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Gilead's Descovy backed by US FDA panel as HIV prevention therapy

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Gilead's Descovy backed by US FDA panel as HIV prevention therapy

A U.S. Food and Drug Administration advisory panel has backed Gilead Sciences Inc.'s Descovy combination therapy for the prevention of HIV infection in men and transgender women, Reuters reported.

Descovy is a combination treatment of emtricitabine and tenofovir alafenamide, which is already FDA-approved for treating chronic HIV.

At an advisory committee meeting Aug. 7, the panel voted 16-2 in support of the drug to be used for pre-exposure prophylaxis, or PrEP, to prevent HIV in men and transgender women who have sex with men. This group forms the largest group in the PrEP market, according to Reuters.

However, the panel voted 10-8 against supporting the expanded use of Descovy for cisgender women, noting that little evidence exists to support the drug's use for PrEP in this population.

The advisory panel's decision is not the final word on Descovy, and the FDA has yet to officially rule on the drug's approval. The agency typically follows the advice of the independent panel of experts.

Gilead expects the expanded label for Descovy to be approved in the fourth quarter of 2019.