FDA approves Gilead's Descovy for HIV pre-exposure prophylaxis

Gilead Sciences on Thursday announced that the FDA has authorised Descovy (emtricitabine/tenofovir alafenamide) for preventing the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg. The treatment is the second drug cleared in the US for HIV pre-exposure prophylaxis (PrEP) following the approval of Truvada (emtricitabine/tenofovir disoproxil fumarate) in 2012. Gilead CEO Daniel O'Day remarked "Descovy for PrEP provides a new HIV prevention option that matches Truvada's high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time."  

Approval of Descovy for this indication was backed by data from the Phase III DISCOVER study, whose results unveiled in March showed that once-daily Descovy was proven to have non-inferior efficacy to Truvada in preventing HIV-1 infection among men who have sex with men and transgender women at risk for sexually acquired HIV infection. 

The drugmaker noted however that Descovy for PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.

In August, an FDA advisory panel voted 16-2 in favour of approving Descovy for HIV PrEP in men and transgender women. However, the panel voted 10-8 against approving the treatment for use in cisgender women. 

Descovy was initially cleared by the FDA in 2016 for use in combination with other antiretroviral therapies for the treatment of HIV-1 infection in adults and children aged 12 and older. Sales of the drug in the second quarter totalled $358 million, down from $403 million in the year-ago period.  

For related analysis, see ViewPoints: Gilead's moonshot with Descovy likely to land among the stars

 

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