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.
It is administered as a twice-yearly subcutaneous injection following an initial phase that includes one injection and oral tablets on Days 1 and 2.
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.”
The Authority conducted a comprehensive evaluation of Lenacapavir’s safety, efficacy, and quality, drawing on scientific assessments from the World Health Organisation’s Prequalification Programme to support an efficient review.
Zimbabwe’s approval comes as regional interest in Lenacapavir surges. Last week, Eswatini became the first country to receive doses under a new United States–led global delivery programme.
The initiative, operating under the America First Global Health Strategy, aims to supply high-burden countries with the first 600,000 available doses in 2026.
Brad Smith, Senior Advisor in the U.S. Bureau of Global Health Security and Diplomacy, said initial procurement projections were far lower but were expanded in response to increased demand from African governments.
The U.S. Government and the Global Fund have now secured the entire global stock for next year.
Global Fund Executive Director Peter Sands noted that the drug’s deployment would be data-driven, prioritising populations most at risk.
He added that Zimbabwe is among the countries “well advanced” in preparing a national rollout plan, with implementation strategies being finalised in collaboration with PEPFAR.
Eswatini, which has surpassed the UNAIDS 95-95-95 treatment targets, will prioritise its first doses for high-risk groups, including women of reproductive age, pregnant and breastfeeding mothers, and young people.
Similar priority considerations are expected in Zimbabwe once its allocations arrive.
