FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Approves Descovy as HIV Prevention Treatment

Oct. 16, 2019
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Gilead earned the FDA’s approval for Descovy (emtricitabine 200mg and tenofovir alafenamide 25mg) for HIV-1 pre-exposure prophylaxis (PrEP).

The approval marks the second PrEP drug approved for HIV. Descovy is taken daily by patients who do not have the virus. Trial data showed the risk reduction is similar to that of Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate).

Gilead said that Descovy offers “statistically significant improvements in renal and bone safety” compared to Truvada, which can be important for at-risk patients that use PrEP over a long period.

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