www.fdanews.com/articles/176092-gileads-descovy-earns-fda-approval
Gilead’s Descovy Earns FDA Approval
April 11, 2016
The FDA has approved Gilead Sciences’ combination therapy Descovy for the treatment of HIV-1 infection in adults and pediatric patients.
Indicated for use with other antiretroviral agents in patients 12 and older, the drug is a combination of emtricitabine and tenofovir alafenamide F/TAF. Descovy earned a positive recommendation from the European Medicines Agency in February.
Descovy carries a boxed warning on the risks of lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.