Zambia's medicines regulator approved the HIV prevention drug lenacapavir in 12 days, a stark contrast to typical four- to seven-year delays in sub-Saharan Africa. Lenacapavir, a twice-yearly injection developed by Gilead Sciences, showed over 99.9% efficacy in trials and addresses adherence and stigma issues with daily oral PrEP. Gilead employed regulatory reliance, allowing Zambia to leverage assessments from better-resourced regulators rather than conducting independent reviews.
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Zambia's medicines regulator approved the HIV drug lenacapavir in just 12 days by using regulatory reliance, a streamlined approach that decomposes the approval process. Lenacapavir, a twice-yearly injection developed by Gilead Sciences, showed over 99.9% efficacy in preventing HIV infection and addresses adherence and stigma problems associated with daily oral PrEP. The rapid approval demonstrates how resource-constrained regulators in low- and middle-income countries can accelerate access to critical medicines.