FDA Approves Gilead's Biannual HIV Shot for Long-Term Protection

• FDA approved Yeztugo (lenacapavir) for twice-yearly HIV prevention
• Lenacapavir is a capsid inhibitor with near 100% efficacy in trials
• Yeztugo could replace daily PrEP pills with just two annual shots

In a HIV prevention milestone, the US Food and Drug Administration (FDA) has approved Gilead Sciences' lenacapavir, a twice-a-year long-acting injection, for adults and adolescents at risk of HIV infection. The product will be sold under the brand name Yeztugo.

Lenacapavir is a new type of HIV drug called a capsid inhibitor and was highly effective, with near 100 percent success rate against HIV in big clinical trials in 2023. The results have generated hope that the drug might be one of the decisive tools to stop the pandemic of HIV, which still infects more than 1.3 million people worldwide every year.

The investors and the worldwide HIV activist community had been holding their breath for approval. They view Yeztugo as the tipping point in the war on the 44-year HIV pandemic. In July, journal Science chose lenacapavir as its 2024 Breakthrough of the Year, praising its revolutionary potential as a pre-exposure prophylaxis (PrEP) medication.

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United States, Gilead spokeswoman Blair Baumwell wrote an email on this Wednesday, and she stated, “We believe lenacapavir is the most important tool yet to bend the arc of the epidemic and move it into the history books.” 

With FDA clearance in pocket, Gilead is ready to bring Yeztugo to the U.S. market in the near term and plans to broaden access with partnerships with international health organizations.

The Yeztugo approval marks a new bold age of HIV prevention, one where two-shot shots may replace once-daily pills and hold out the promise of an HIV-free future.