07/11/2025
ZAMRA APPROVES LENACAPAVIR FOR HIV PREVENTION 🇿🇲🧬
The Zambia Medicines Regulatory Authority (ZAMRA) has approved lenacapavir, a long-acting capsid inhibitor formulated as a twice-yearly injectable pre-exposure prophylaxis (PrEP) for HIV prevention.
This decision positions Zambia as the second country in Africa and the fourth globally to authorize this innovative HIV prevention option. Lenacapavir offers six-monthly subcutaneous dosing, providing a powerful alternative for individuals who face challenges with adherence to daily oral PrEP regimens.
Beyond its clinical impact, this regulatory milestone highlights ZAMRA’s growing technical capacity and alignment with international regulatory standards, reinforcing the role of African national regulatory authorities in evaluating and enabling access to cutting-edge biomedical interventions.
The next critical steps will involve:
1. Integrating long-acting PrEP into national HIV prevention guidelines.
2. Ensuring equitable, affordable access for populations at highest risk (especially adolescent girls, and young women).
3. Generating implementation and real-world effectiveness data to guide scale-up
This is an important signal that Zambia and Africa more broadly can play a leading role in the timely adoption and governance of novel HIV prevention technologies.
