In a landmark step for global HIV prevention efforts, the World Health Organization (WHO) has applauded the recent approval by the U.S. Food and Drug Administration (FDA) of lenacapavir—a powerful new injectable medication shown to be highly effective at preventing HIV.
Given just twice a year, lenacapavir offers long-acting protection against the virus, marking a breakthrough for public health. Its approval follows exceptional results from the 2024 PURPOSE 1 and PURPOSE 2 clinical trials, which confirmed the drug’s safety and effectiveness across multiple populations and global settings.
“This is a pivotal moment,” said Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis, and STI Programmes. “Lenacapavir could transform the landscape of HIV prevention, especially for those who face challenges with daily pills or frequent clinic visits.”
Why Lenacapavir Matters: A Game-Changer in Prevention
WHO already endorses several pre-exposure prophylaxis (PrEP) options for HIV, including:
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Daily oral PrEP (e.g., Truvada)
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The dapivirine vaginal ring
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Long-acting injectable cabotegravir (CAB-LA)
Now, lenacapavir brings a next-generation option into the mix. Its discreet dosing schedule—only two injections per year—is poised to improve uptake, especially among populations for whom stigma, inconvenient regimens, or clinic access barriers have hindered consistent PrEP use.
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Public health experts hope lenacapavir will have a particular impact in:
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Young women and adolescent girls in sub-Saharan Africa
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LGBTQ+ individuals facing discrimination
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People who inject drugs
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Sex workers and mobile populations
Global Access on the Horizon
WHO is preparing to release official guidelines for lenacapavir use on July 14, 2025, during the International AIDS Conference in Kigali, Rwanda—an event expected to draw thousands of scientists, advocates, and global leaders.
The FDA’s approval not only opens doors in the United States but also triggers a critical next step: WHO prequalification. This mechanism accelerates the path for global distribution, enabling:
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Faster national regulatory approvals, especially in low- and middle-income countries
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Procurement by major donors such as the Global Fund, PEPFAR, and UNITAID
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Inclusion in public health supply chains serving millions worldwide
WHO is also coordinating closely with the European Medicines Agency (EMA) under the Medicines 4 All (M4All) initiative to support regulatory pathways in countries eager to adopt lenacapavir.
From Innovation to Impact: The Real Work Begins
While the drug’s approval is a major scientific milestone, equitable distribution remains the next big hurdle. WHO stresses that no prevention tool can reach its full potential without sustained investment in health system infrastructure, community outreach, and affordable access.
To meet this challenge, WHO is collaborating with a wide range of partners—from ministries of health and pharmaceutical firms to grassroots NGOs—to ensure swift, safe, and fair delivery of lenacapavir to the people who need it most.
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“This isn’t just a new drug,” said Dr. Doherty. “It’s a new opportunity to close gaps in HIV prevention and make progress toward a world without AIDS.”
What’s Next?
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July 14, 2025: WHO will release detailed global guidelines on lenacapavir use in HIV prevention during the International AIDS Conference.
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Prequalification Process: With FDA approval in hand, lenacapavir is on track for fast-track WHO prequalification, unlocking donor procurement.
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Global Rollout Planning: Countries are already preparing regulatory pathways, training health workers, and assessing funding models for widespread adoption.
With the addition of lenacapavir to the HIV prevention toolkit, the global community stands at the brink of unprecedented progress—if access is prioritized and no one is left behind.
