The US Food and Drug Administration (FDA) gave expanded approval for Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for pre-exposure prophylaxis (PrEP), adding to its prior indication for use as a treatment for HIV-1 infection, in combination with antiretroviral agents.
The treatment will be available for adults and adolescents weighing at least 35kg and at-risk for sexually acquired HIV; however, the approval does not include women.
Descovy will become Gilead’s second drug to receive such an approval, after Truvada (emtricitabine/tenofovir disoproxil fumarate) – the latter treatment is set to face generic rivals in September 2020.
In a Phase III study, the newly approved treatment was able to prove non-inferiority when compared to Truvada and additional second endpoints were met suggesting that Descovy holds advantages in renal and bone safety.
“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,” said Daniel O’Day, CEO at Gilead Sciences.
Prior to the approval, Gilead had continued to invest in HIV therapies, with the company announcing an exclusive collaboration with Lyndra Therapeutics to develop and commercialize oral therapies for HIV.