• U.S. FDA approves Gilead’s Descovy for HIV prevention

    • October 5, 2019
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    The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s (GILD.O) Descovy to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men.

    The approval does not include use of the drug by women to prevent HIV infection.

    Descovy, a combination drug, was approved in 2016 to treat people already infected with HIV. It contains a newer formulation of a drug used in Gilead’s older medication, Truvada, which has been used to treat people infected with HIV since 2004.

    Truvada was also approved as a daily pill for pre-exposure prophylaxis, or PrEP, in 2012. Gilead has said it aims to transition PrEP use from Truvada to Descovy before the older drug loses patent protection, which is expected next year.

    The company said on Thursday that its list price for both Truvada and Descovy is $1,758 per month.

    The FDA-approved label for Descovy, while more limited than Truvada’s, “comes as expected,” RBC Capital Markets analyst Brian Abrahams said in a research note. “The key will be the extent to which Gilead can transition the market to branded Descovy ahead of Truvada’s genericization in around one year.”


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