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Tag: Lenacapavir

Breakthrough Approved: FDA Greenlights Revolutionary Six-Month HIV Prevention Drug

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,…

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FDA Approves Lenacapavir (Yeztugo) as Twice-Yearly HIV Prevention Injection

FDA Approves Lenacapavir (Yeztugo) as Twice-Yearly HIV Prevention Injection

FDA Approves Lenacapavir (Yeztugo) as Twice-Yearly HIV Prevention Injection On June 19, 2025, the Food and Drug Administration (FDA) approved lenacapavir, marketed as Yeztugo, as the first twice-yearly injection for pre-exposure prophylaxis (PrEP) to prevent HIV infection. Previously approved in 2012 under the name Sunlenca as a treatment for HIV in individuals who no longer responded to other medications, lenacapavir’s mechanism involves targeting a protective shell HIV needs to survive, disrupting its growth and spread. Unlike most HIV drugs that…

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Lenacapavir: A Twice-Yearly HIV Prevention Injection Approved by the FDA – Promise and Challenges

Lenacapavir: A Twice-Yearly HIV Prevention Injection Approved by the FDA – Promise and Challenges

Lenacapavir: A Twice-Yearly HIV Prevention Injection Approved by the FDA – Promise and Challenges The Food and Drug Administration (FDA) has approved Gilead Sciences’ lenacapavir as a twice-yearly pre-exposure prophylaxis (PrEP) injection, marking a significant advancement in HIV prevention. This approval follows successful Phase III clinical trials demonstrating a remarkably high efficacy rate, exceeding that of daily PrEP regimens. The drug, marketed under the brand name Yeztugo, achieved a 100% prevention rate in cisgender women and a 99.9% prevention rate…

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Lenacapavir: A Promising HIV Prevention Breakthrough and its Global Accessibility Challenges

Lenacapavir: A Promising HIV Prevention Breakthrough and its Global Accessibility Challenges

Lenacapavir: A Promising HIV Prevention Breakthrough and its Global Accessibility Challenges The recent FDA approval of lenacapavir marks a significant advancement in HIV prevention. This long-acting injectable drug, administered just twice yearly, offers a compelling alternative to daily oral PrEP (pre-exposure prophylaxis) medications like Truvada. Clinical trials, including PURPOSE 1 and PURPOSE 2, demonstrated remarkably high efficacy rates, approaching near-complete protection against HIV infection in diverse populations. These results, hailed as a “Breakthrough of the Year” by Science in 2024,…

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