HARARE – Zimbabwe has officially fast-tracked the approval of Lenacapavir, a pioneering long-acting HIV prevention drug, becoming one of the first countries in the region to authorise its use as a pre-exposure prophylaxis (PrEP) option. The Medicines Control Authority of Zimbabwe (MCAZ) confirmed that the application, submitted by Gilead Sciences on 29 October 2025, was reviewed and approved in a record 23 days under the Authority’s expedited regulatory process. MCAZ said the rapid assessment reflects the drug’s “major public health importance,” both locally and globally, as the country continues efforts to curb new HIV infections.
Lenacapavir is recommended for use alongside safer sex practices in adults and adolescents weighing at least 35 kg who are HIV-negative and at substantial risk of infection. Health authorities say the product offers a significant alternative to daily oral PrEP, with the potential to improve adherence and expand prevention choices for vulnerable populations. “The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products,” MCAZ Director-General Richard Tendayi Rukwata said. “This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health.” Zimbabwe selected for global rollout of breakthrough HIV…Sep 23, 202539,954 Zimbabwe selected for global rollout of breakthrough HIV… Zimbabwe records slight rise in HIV/AIDS deaths amidst…Jun 19, 202525,097 Zimbabwe records slight rise in HIV/AIDS deaths amidst… HIV patients in Zimbabwe breathe huge sigh of relief as US…Jan 29, 202541,251
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