Matpulse Reporter
The Medicines Control Authority of Zimbabwe (MCAZ) has fast-tracked the approval of Lenacapavir, a long-acting injectable medicine for pre-exposure prophylaxis (PrEP) aimed at preventing HIV-1 infection.
The regulatory authority announced on Friday that the product was evaluated and authorised in just 23 days under its expedited review pathway. The decision, made by the Authority’s Registration Committee, was reached through an expedited review process due to the drug’s designation as being of “major public health importance both in Zimbabwe and globally.” The application, submitted by pharmaceutical company Gilead on October 29, 2025, successfully passed a rigorous evaluation and was finalised on November 22, 2025.
Lenacapavir offers a significant development in HIV prevention, offering a long-acting alternative to the current standard of daily oral PrEP. It is intended for HIV-negative adults and adolescents weighing at least 35 kg who are at substantial risk of HIV infection.
MCAZ stated the product is administered as a six-monthly subcutaneous injection following a short initiation phase involving one injection and oral tablets taken on Days 1 and 2. It must be used alongside safer sex practices, including condom use and behavioural risk-reduction measures.
Richard T. Rukwata, the MCAZ Director-General, emphasised the importance of this rapid turnaround. “The rapid approval of Lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products,” Rukwata said in the media release. “This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health.”
The Authority believes the long-acting nature of the product has the potential to significantly improve patient adherence, thereby expanding effective prevention options, particularly for populations most vulnerable to HIV infection.
MCAZ said its review included a comprehensive assessment of Lenacapavir’s safety, efficacy, and quality. The Authority also relied on scientific evaluations from the World Health Organization Prequalification (WHO PQ) programme to support an efficient regulatory process.
The agency reiterated its commitment to ensuring that Zimbabweans have access to safe, effective, and quality-assured medical products as part of the ongoing effort to combat HIV and AIDS.
