Cape Town – The South African Health Products Regulatory Authority (SAHRA) has approved the registration of Lenacapavir, a revolutionary injection designed to prevent the Human Immunodeficiency Virus (HIV).
According to Dr Boitumelo Semete-Makokotlela, the injection is an antiviral medicine recommended for use in combination with safer sex practices as pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection in adults and adolescents weighing at least 35 kg.
“An application by Gilead was submitted to SAHPRA in March 2025. The SAHPRA review process was done in collaboration with the European Medicines for All Procedure (EU-M4all).
“This procedure enables the European Medicines Agency (EMA), together with the participating regulatory authorities, to provide scientific opinions on high-priority medicines, such as Lenacapavir, intended for markets outside the European Union.
SAHPRA approves the registration of Lenacapavir. pic.twitter.com/yWCBpZnSXY
— Nonhlanhla M👩🏽⚖️⚖️ (@Attorney_Bae) October 28, 2025
“The benefits of this pathway are to strengthen regulatory systems and accelerate access to essential medicines,” said Semete-Makokotlela.
The product helps prevent new HIV infections and is administered every six months. The treatment begins with an initial subcutaneous injection, followed by tablets taken over two days after the first dose.
It reduces the risk of contracting HIV in adults and adolescents who weigh at least 35 kg, who are HIV negative and are at risk of getting HIV.
Lenacapivir should always be used with a combination safer sex practice, such as using condoms to prevent other, to reduce the risk of getting other sexually transmitted infections.
Congratulations to South Africa🇿🇦 for becoming the first African country to register the twice-a-year anti-HIV jab, Lenacapavir (LEN), a milestone in HIV prevention & health innovation.
This breakthrough brings us closer to ending AIDS as a public health threat.… pic.twitter.com/cclPNMMI7X— WHO South Africa (@WHOSouthAfrica) October 27, 2025
“The registration of Lenacapavir is a game-changer, given the high prevalence rate of HIV in South Africa. This product is the most effective HIV prevention measure thus far,” concluded Semete-Makokotlela
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Compiled by Anda Tolibadi
