Oct 3 (Reuters) - The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s drug, Descovy, to reduce the risk of sexually acquired HIV infection.
The expanded label is a combination of emtricitabine and tenofovir alafenamide, and is already approved to treat chronic HIV.
The drug’s use excludes individuals who are at-risk of acquiring HIV from receptive vaginal sex because its effectiveness in this population has not been evaluated, the FDA said.
The recommendation is a shot in the arm for Gilead as its third best-selling HIV drug, Truvada, faces exclusivity loss in the United States, beginning 2020.
An FDA panel in August recommended approval for the drug in reducing the risk of HIV infection in men and transgender women who have sex with men.
Nearly 40,000 people received an HIV diagnosis in the U.S. in 2017, according to the Centers for Disease Control and Prevention. (Reporting by Manas Mishra in Bengaluru; Editing by Shailesh Kuber)