Pretoria: The South African Health Products Regulatory Authority (SAHPRA) has announced the registration of lenacapavir, making South Africa the first country on the continent to approve the innovative twice-a-year anti-HIV injection.
According to South African Government News Agency, in March 2025, Gilead, a biopharmaceutical company based in the United States, applied to SAHPRA, the local drug regulatory authority. Two weeks ago, Health Minister Dr. Aaron Motsoaledi announced plans to launch lenacapavir, a pioneering long-acting HIV prevention method, as early as March 2026. The Minister was speaking at the national roundtable on lenacapavir access and sustainability in South Africa.
The South African National AIDS Council (SANAC) and the Department of Health held a multi-stakeholder roundtable session to discuss the country’s readiness to implement lenacapavir. Lenacapavir is a long-acting injectable drug that offers six months of protection with just two annual doses. At the national roundtable meeting, Motsoaledi highlighted the drug’s potential to address critical gaps in current HIV prevention methods.
Meanwhile, SAHPRA stated that the review process was conducted in collaboration with the European Medicines for All Procedure. ‘This procedure enables the European Medicines Agency, together with the participating regulatory authorities, to provide scientific opinions on high-priority medicines, such as lenacapavir, intended for markets outside the European Union. The benefits of this pathway are to strengthen regulatory systems and accelerate access to essential medicines,’ the watchdog explained.
The product, developed to prevent new HIV infections, is administered as a six-monthly injection. There is an initiation dose of a subcutaneous injection with tablets taken on days one and two. ‘It is used to reduce the risk of HIV in adults and adolescents who weigh at least 35 kg, are HIV negative, and are at risk of getting HIV,’ SAHPRA said.
According to SAHPRA, lenacapavir for pre-exposure prophylaxis (PrEP) should always be used in combination with safer sex practices, such as using condoms, to reduce the risk of acquiring other sexually transmitted infections. ‘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,’ said SAHPRA CEO, Boitumelo Semete-Makokotlela.
Earlier this month, Motsoaledi announced plans to integrate lenacapavir into domestic financing mechanisms, aiming for routine funding after two years. He stated that Gilead and six pharmaceutical companies, including one in Egypt, will produce the jab for US$40 per person per year, a significant reduction from US$28,000, reducing costs by 700 times. Additionally, Motsoaledi mentioned that pharmaceutical companies like Hetero and partnerships with the Gates Foundation will produce generic versions, while South Africa actively pursues local manufacturing capabilities.
SAHPRA is tasked with monitoring, evaluating, investigating, inspecting, and registering all health products. This includes clinical trials, complementary medicines, medical devices, and in-vitro diagnostics and has also added the responsibility of overseeing radiation control in South Africa.