FDA Approves Breakthrough HIV Drug
- The Food and Drug Administration on Wednesday approved lenacapavir, a long-acting injectable drug for HIV prevention, manufactured by Gilead Sciences.
- Gilead CEO Daniel O'Day hailed the approval as "a historic day" and "one of the most important scientific breakthroughs" in the fight against HIV, offering a chance to...
- One trial showed 100% effectiveness in blocking HIV infection, while another showed 99.9% effectiveness among participants receiving the HIV prevention drug as pre-exposure prophylaxis (PrEP).
The FDA has approved lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection” title=”Yeztugo … Is Now the First and Only FDA Approved HIV …”>Yeztugo (lenacapavir), a groundbreaking injectable drug for HIV prevention, marking a notable advancement in pre-exposure prophylaxis (PrEP). Clinical trials displayed remarkable efficacy,with some showing nearly perfect protection against HIV infection. This new HIV role for an injectable comes at a crucial moment, yet faces the context of funding cuts to global AIDS research and aid. News Directory 3 reports on Gilead Sciences’ new drug and its implications, highlighting the importance of this advancement amidst budget concerns.Stay informed about the impact of these changes on treatment accessibility. Discover what’s next …
FDA Approves Injectable HIV Prevention Yeztugo Amid Funding Concerns
Updated June 19, 2025
The Food and Drug Administration on Wednesday approved lenacapavir, a long-acting injectable drug for HIV prevention, manufactured by Gilead Sciences. The drug will be marketed as Yeztugo, offering a new pre-exposure prophylaxis (PrEP) option.
Gilead CEO Daniel O’Day hailed the approval as “a historic day” and “one of the most important scientific breakthroughs” in the fight against HIV, offering a chance to end the HIV epidemic.
Clinical trials demonstrated Yeztugo’s high efficacy. One trial showed 100% effectiveness in blocking HIV infection, while another showed 99.9% effectiveness among participants receiving the HIV prevention drug as pre-exposure prophylaxis (PrEP). This new HIV role for an injectable drug is a notable advancement.
Though, the approval occurs as the Trump administration implements significant cuts to global AIDS research and aid programs.
These cuts include reductions to the United States Agency for International Advancement (USAID) and the President’s Emergency Plan for AIDS Relief (PEPFAR), which has saved an estimated 26 million lives as 2003. Several HIV prevention studies have also been shut down, including the MATRIX study, a $125 million USAID-funded project evaluating new HIV prevention products for women.
Dr. Catherine Chappell,an assistant professor and OB-GYN at the University of Pittsburgh,said the abrupt end to her phase I clinical trial for a vaginal ring due to the executive order was “wholly unethical” and could damage relationships with the community in South Africa.
A former USAID analyst said further clinical trials for lenacapavir had also been canceled.
“We’re on the precipice of now being able to deliver the greatest prevention option we’ve had in 44 years of this epidemic. And it’s as if that opportunity is being snatched out of our hands by the policies of