Breakthrough Approved: FDA Greenlights Revolutionary Six-Month HIV Prevention Drug
Breakthrough Approved: FDA Greenlights Revolutionary Six-Month HIV Prevention Drug
In a landmark decision last week, the U.S. Food and Drug Administration (FDA) approved lenacapavir, an innovative antiviral drug for HIV prevention, now marketed as Yeztugo. This approval marks a significant leap forward in the fight against HIV, making a highly effective, long-lasting preventative measure available in the United States.
The drug’s development stems directly from the pioneering work of University of Utah biochemist Wesley Sundquist and his lab. For decades, Sundquist’s team laid the crucial scientific groundwork by meticulously analyzing the HIV virus’s protein shell, discovering its vulnerabilities. These foundational insights attracted the attention of California-based pharmaceutical giant Gilead Sciences, which then developed lenacapavir, tapping Sundquist as a key consultant.
What makes Yeztugo particularly revolutionary is its unparalleled potency and extended efficacy. Unlike many existing HIV treatments, lenacapavir binds to the virus’s protein shell, disrupting its assembly and preventing it from properly infecting host cells. Clinical trials have demonstrated its remarkable ability to protect individuals from HIV transmission for a full six months with a single dose. Sundquist himself highlighted, “It’s more potent than any drug available, but more importantly, it’s very long-lasting.”
This approval comes at a critical time, with approximately 31,000 new HIV infections reported annually in the U.S. and 1.3 million new infections worldwide. The drug’s potential for widespread impact is immense, especially given its success in large clinical trials conducted in HIV hotspots like South Africa and Uganda, where over 2,000 women receiving the drug experienced no HIV contractions during the study. “Lenacapavir almost completely prevents the transmission of HIV into at-risk populations,” Sundquist noted, calling it an “amazing result.”
The FDA’s decision adds to a string of recent accolades for Sundquist, who was also awarded the prestigious 2025 Warren Alpert Prize from Harvard University last week and was recognized by Time magazine in April as one of the world’s 100 most influential people. Despite these significant achievements, Sundquist remains focused on the future, emphasizing the ongoing need for a comprehensive HIV vaccine to protect all individuals. This latest approval, however, undeniably offers a powerful new weapon in the global effort to end the HIV epidemic.
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