LUSAKA — For the first time ever, African health authorities have approved a game-changing HIV prevention drug in record time. Zambia and Zimbabwe just authorized lenacapavir, a twice-yearly injectable that’s being hailed as the future of HIV prevention. And here’s the kicker—Zambia did it in just 12 working days.
What Makes This Approval So Special
This isn’t your typical drug approval story. Lenacapavir is the first long-acting pre-exposure prophylaxis (PrEP) that only requires two shots per year instead of daily pills. That’s huge for people who struggle with pill fatigue, stigma, or can’t easily access healthcare.
The approvals came through the WHO’s Collaborative Registration Procedure, which lets countries fast-track decisions by trusting evaluations from reliable regulators. Zambia’s ZAMRA completed its review on November 4, 2025, and Zimbabwe’s MCAZ followed just days later with an 18-day turnaround.
“These swift approvals demonstrate how regulatory innovation meets urgent public health needs,” said Hiiti Silo, Unit Head at WHO’s Regulation and Prequalification Department. “It’s what becomes possible when we use smart pathways.”
Why This Matters for HIV Prevention
Let’s be honest—getting people to stick with daily HIV prevention pills has always been a challenge. Life gets in the way. Stigma keeps folks from picking up prescriptions. Some people just don’t have easy access to pharmacies or clinics.
A twice-yearly shot changes the game. You show up, get your injection, and you’re protected for six months. No daily reminders. No pill bottles to hide. No trips to the pharmacy every month.
With World AIDS Day marking these approvals, health experts see this as a critical tool to finally end new HIV infections across Africa. Clinical trials showed lenacapavir is highly effective, giving hope to millions at risk.
What’s Next
Other African countries are already lining up to review lenacapavir through the same WHO pathway. The goal? Get this prevention option to as many people as possible, as fast as possible.
Bottom line? This is a big win for Africa’s fight against HIV. Fast approvals like these prove that when health systems work smart, lives get saved. And honestly, that’s what matters most.
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