BY WANDILE TSHUMA
Zimbabwe has taken a major step in the fight against HIV following the rapid approval of Lenacapavir, a groundbreaking long-acting injectable for HIV pre-exposure prophylaxis (PrEP). The Medicines Control Authority of Zimbabwe (MCAZ) authorised the drug in just 23 days, marking one of the fastest regulatory approvals in the country’s history.
The application, submitted by pharmaceutical company Gilead Sciences in October, underwent an expedited review because of its public health importance. MCAZ says the fast-tracked process did not compromise scientific scrutiny, with the product subjected to a rigorous assessment of its safety, efficacy and quality.
Lenacapavir is designed for adults and adolescents weighing at least 35kg who are HIV-negative but at substantial risk of infection. Unlike traditional daily oral PrEP, the medicine is administered as a six-monthly injection, following an initiation phase that includes one injection and oral tablets on Days 1 and 2. Health authorities say this long-acting formulation could dramatically improve adherence and expand prevention options, particularly for communities where daily pill-taking is difficult.
MCAZ Director-General Richard T. Rukwata described the approval as a landmark moment in Zimbabwe’s HIV response.
“The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products. This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health,” he said.
To fast-track the process, the Authority applied a regulatory reliance approach, drawing on scientific assessments from the World Health Organization’s Prequalification Programme (WHO PQ). This allowed evaluators to build on internationally recognised review processes while ensuring Zimbabwe’s own standards were met.
The introduction of Lenacapavir comes as Zimbabwe continues efforts to reduce new HIV infections, particularly among young people and key populations who face barriers to consistent PrEP use. Public health experts say the drug’s twice-yearly dosing could be a game changer in improving uptake and protection.
MCAZ says it remains committed to ensuring Zimbabweans have access to safe, effective and good-quality medical products, in line with its mandate under the Medicines and Allied Substances Control Act.