NATIONAL NEWS - The South African Health Products Regulatory Authority (SAHPRA) has registered lenacapavir, making South Africa the first country on the continent to approve the twice-a-year anti-HIV injection.
In March, US-based biopharmaceutical company Gilead applied to SAHPRA for approval.
Launch planned for 2026
Two weeks ago, Health Minister Dr Aaron Motsoaledi said South Africa plans to launch lenacapavir, a long-acting HIV prevention method, as early as March 2026.
He was speaking at a national roundtable on lenacapavir access and sustainability. The South African National AIDS Council and the Department of Health held the multi-stakeholder session to discuss the country’s readiness to implement the drug.
How Lenacapavir works
Lenacapavir is a long-acting injectable drug offering six months of protection with just two annual doses. At the national roundtable, Motsoaledi highlighted its potential to address critical gaps in current HIV prevention methods.
SAHPRA stated that its review was done in collaboration with the European Medicines for All Procedure.
“This procedure enables the European Medicines Agency, with 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 said.
LISTEN: Sahpra registers Lenacapavir
The product is a six-monthly injection with an initiation dose of a subcutaneous injection, combined 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 35kg, are HIV negative, and are at risk of getting HIV,” SAHPRA said.
Lenacapavir for pre-exposure prophylaxis should always be used alongside safer sex practices, such as using condoms, to reduce the risk of other sexually transmitted infections.
A game-changer for HIV prevention
“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 said government plans to integrate lenacapavir into domestic financing mechanisms, aiming for routine funding after two years. Gilead and six pharmaceutical companies, including one in Egypt, will produce the jab for US$40 per person per year — a 700-fold reduction from US$28 000.
Pharmaceutical companies such as Hetero, in partnership with the Gates Foundation, will produce generic versions, while South Africa pursues local manufacturing capabilities.
SAHPRA’s expanded role
SAHPRA is responsible for monitoring, evaluating, investigating, inspecting and registering all health products. This includes clinical trials, complementary medicines, medical devices, in-vitro diagnostics and now also overseeing radiation control in South Africa. – SAnews.gov.za
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