By Bunmi Yekini
The South African Health Products Regulatory Authority (SAHPRA) has approved the registration of Lenacapavir, a long-acting injectable medicine for pre-exposure prophylaxis (PrEP) that prevents HIV-1 infection in adults and adolescents weighing at least 35 kilograms.
Developed by U.S.-based biopharmaceutical company Gilead Sciences, Lenacapavir is administered once every six months and is used alongside safer sex practices such as condom use to reduce the risk of acquiring HIV and other sexually transmitted infections.
“The registration of Lenacapavir is a game-changer, given the high prevalence rate of HIV in South Africa,” said Dr. Boitumelo Semete-Makokotlela, SAHPRA’s chief executive officer. “This product is the most effective HIV prevention measure thus far.”
Gilead submitted its application for Lenacapavir in March 2025. SAHPRA’s review was conducted in collaboration with the European Medicines Agency (EMA) under the European Medicines for All (EU-M4all) procedure, which facilitates scientific opinions on high-priority medicines intended for markets outside the European Union.
According to SAHPRA, this collaborative review process aims to strengthen regulatory systems and speed up access to essential medicines in regions with high disease burdens.
Lenacapavir’s regimen begins with an initiation dose, a subcutaneous injection given under the skin, accompanied by oral tablets taken on days one and two. It is recommended for HIV-negative adults and adolescents who are at substantial risk of HIV infection.
South Africa continues to bear one of the world’s highest HIV prevalence rates, with millions relying on daily PrEP pills or condoms to prevent infection. Health experts have hailed Lenacapavir’s approval as a critical step toward expanding HIV prevention options and improving adherence among vulnerable populations.