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FDA Hearing Ongoing Wed Aug 7 2019 on Descovy for PrEP
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FDA panel backs Gilead's HIV prevention drug for certain population
https://www.reuters.com/article/us-gilead-sciences-fda/fda-panel-backs-gileads-hiv-prevention-drug-for-certain-population-idUSKCN1UX2DD
REUTERS: Independent experts on an FDA advisory panel on Wednesday voted in favor of Gilead Sciences Inc's combination drug to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men.
The treatment, Descovy, is a combination of emtricitabine and tenofovir alafenamide, and is an approved treatment for chronic HIV.
The panel voted 16-2 in favor when asked to assess the efficacy of Descovy for pre-exposure prophylaxis (PrEP) of HIV in men and transgender women who have sex with men, who form the largest component of the PrEP market.
However, the panel said there was not enough data to support the expansion of Descovy's label for use as a preventive HIV drug for cisgender women.
The panel voted 10-8 against its approval in the population.
The FDA is yet to make a final decision on Descovy's approval for PrEP. While the agency is not bound to follow the advice of its advisory panels, it usually does so.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Arun Koyyur)
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