HIV injection Lenacapavir approved, but at what cost? EFF demands local production amid licensing row

By Marcus Moloko

South Africa’s registration of Lenacapavir (LEN) marks a significant milestone in the country’s fight against HIV and AIDS.

The South African Health Products Regulatory Authority (SAHPRA) recently announced the registration of Lenacapavir, making South Africa the first country on the continent to approve the twice-a-year anti-HIV injection.

Gilead Sciences, the drug manufacturer, has excluded South Africa from the licensing agreement, citing technical specifications as justification. The exclusion means the country must rely on imported versions of LEN, which are often priced above public health budgets.

This also prevents South Africa from developing domestic capacity to produce and distribute the drug at scale, thereby hindering the creation of a resilient healthcare system.

Two weeks ago, Health Minister Dr Aaron Motsoaledi, speaking at the national roundtable, announced that South Africa planned to launch Lenacapavir in March 2026.

While Motsoaledi highlighted the drug’s potential to address critical gaps in current