In a groundbreaking move to combat the HIV/AIDS epidemic, the Medicines Control Authority of Zimbabwe (MCAZ) has approved the long-acting HIV pre-exposure prophylaxis (PrEP) medication, Lenacapavir, in an unprecedented 23 days. This swift approval underscores Zimbabwe’s commitment to enhancing access to innovative health solutions and reinforcing its national HIV prevention strategy.
The expedited review process was initiated after Gilead Sciences submitted an application for Lenacapavir on 29 October 2025. The MCAZ’s Registration Committee undertook a rigorous, yet efficient, evaluation of the product’s safety, efficacy, and quality — a process that typically takes several months — and concluded with approval on 22 November. This rapid turnaround demonstrates MCAZ’s dedication to ensuring timely access to vital medicines, especially those of significant public health importance.
Lenacapavir is a novel, long-acting injectable medication designed to prevent HIV infection in high-risk populations. Administered as a subcutaneous injection every six months after an initial phase involving oral tablets and an injection, it offers a convenient alternative to daily oral PrEP. The medication is recommended for adults and adolescents weighing at least 35 kilograms, functioning as part of a comprehensive HIV prevention strategy that includes safer sex practices such as condom use and behavioural risk reduction.
Speaking about the approval, MCAZ Director-General Mr. Richard T. Rukwata remarked, “The rapid approval of Lenacapavir reflects our unwavering commitment to accelerating access to trusted, high-quality health products. This milestone not only signifies a major step forward in Zimbabwe’s fight against HIV/AIDS but also offers renewed hope for those most vulnerable to infection.”
He further explained that the decision was made after a thorough assessment based on scientific evaluations, with the authority leveraging a reliance approach that incorporated assessments from the World Health Organization’s Prequalification (WHO PQ) programme. This approach allowed for an efficient review while maintaining rigorous safety standards.
The introduction of Lenacapavir marks a significant advancement in Zimbabwe’s HIV prevention arsenal. By providing a long-acting alternative to daily pills, it aims to improve adherence among users and expand prevention options for populations at substantial risk of HIV infection, including young adults and vulnerable communities.
Mr. Rukwata emphasised the importance of such innovations, stating, “Our goal is to ensure that every Zimbabwean at risk of HIV has access to effective prevention tools. Lenacapavir’s approval exemplifies our proactive approach to public health, driven by science, safety, and a commitment to saving lives.”
As Zimbabwe continues to strengthen its response to HIV/AIDS, the MCAZ’s swift approval process sets a precedent for the efficient regulation of critical health products, ensuring that life-saving medicines reach those in need without unnecessary delays.
