By Antonio Pequeño IV – Forbes

Yeztugo, a twice-a-year antiviral shot to prevent HIV, was approved by the Food and Drug Administration on Wednesday, marking a major advance in battling AIDS.

Key Facts

  • The drug (which has the generic name lenacapavir) will become available in the U.S. following the approval, though it’s unclear who will initially have access to the drug.
  • Gilead Sciences CEO Daniel O’Day said in a statement the approval could help make the goal of ending HIV “a reality,” saying the injectable “offers a very real opportunity to help end the HIV epidemic.”
  • Yeztugo has an annual list price of $28,218 before insurance, a figure similar to prices of other branded medications approved for the same use, according to CNBC.
  • Gilead’s stock spiked following the approval, though it quickly dropped back down to roughly flat on the day—in line with broader market movements.
  • The approval comes after two clinical Yeztugo trials showed the drug could nearly prevent all HIV infections, with zero infections among 2,134 participants in one trial and two infections among 2,179 participants in another trial.
  • Yeztugo is Gilead’s latest pre-exposure treatment for HIV prevention, as the pharma company has also produced daily oral pills (Truvada and Descovy) to reduce the risk of HIV infection.

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