SAHPRA PAVES WAY FOR LENACAPAVIR

The South African Health Products Regulatory Authority (SAHPRA) announced the approval, marking a significant milestone in the country’s ongoing efforts to curb new HIV infections.

In March 2025, US-based biopharmaceutical company Gilead applied to SAHPRA to register lenacapavir locally. Months later, Health Minister Dr Aaron Motsoaledi confirmed that the government plans to launch the injection in March 2026.

The announcement was made during a national roundtable on lenacapavir access and sustainability, hosted by the Department of Health and the South African National AIDS Council (SANAC).

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Breakthrough in HIV Prevention Technology

Lenacapavir is a long-acting injectable that provides six months of protection with just two annual doses. The treatment is intended for adults and adolescents weighing at least 35 kg who are HIV-negative and at risk of infection.

At the national roundtable, SAHPRA discussed the importance of expanding prevention options in South Africa, where millions remain vulnerable to HIV. The authority said lenacapavir marks a crucial step forward in reducing infection rates and improving access to care.

“This product is the most effective HIV prevention measure thus far,” said SAHPRA CEO Boitumelo Semete-Makokotlela.

The regulatory review was completed through collaboration with the European Medicines for All Procedure, which works with the European Medicines Agency to assess high-priority medicines.

SAHPRA said this partnership supported scientific transparency and strengthened confidence in the approval process.

“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 authority said.

The agency further stated that international cooperation accelerates patient access to vital medicines and improves regional oversight.

“The benefits of this pathway are to strengthen regulatory systems and accelerate access to essential medicines.”

Ensuring Affordable Access and Local Production

The government plans to make lenacapavir available through domestic funding within two years. The Department of Health said affordability will be central to ensuring the injection reaches all communities in need.

Motsoaledi said Gilead and six pharmaceutical companies, including one based in Egypt, will produce the injection for $40 per person annually, a significant reduction from the original $28 000.

The partnerships are expected to make the drug far more accessible to low- and middle-income countries.

South Africa is also partnering with international foundations and generic manufacturers to strengthen long-term access. The minister said these efforts are aimed at ensuring national self-sufficiency in HIV prevention.

“These partnerships will help ensure that South Africa remains at the forefront of HIV prevention innovation.”

written by Thaabit Kamaar