The approval has been hailed as a game-changer for HIV prevention, particularly for individuals at high risk of infection.
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Uganda has approved the long-acting HIV prevention injection Lenacapavir, marking a significant milestone in the country’s fight against HIV.
The National Drug Authority (NDA) completed the evaluation and licensure of the twice-yearly injectable drug, manufactured by Gilead Sciences, following its high effectiveness in clinical trials among adolescent girls and young women in Uganda and South Africa.
The approval has been hailed as a game-changer for HIV prevention, particularly for individuals at high risk of infection.
However, activists have raised concerns about potential access challenges, citing the limited number of donated doses. The Global Fund’s donation of USD 1.1 million is expected to cover only about 10,000 doses, far below the country’s needs, with Uganda recording up to 1,000 new HIV infections weekly.
The first batch of Lenacapavir is expected to arrive this month, with the Global Fund planning to supply 36,000 doses to nine health facilities in the first quarter of 2026.
In a statement posted on X (formerly Twitter), the NDA said it had completed the evaluation and licensure of the twice-yearly injectable drug manufactured by Gilead Sciences, a United States-based pharmaceutical company.
Uganda has already introduced another long-acting injectable PrEP option, Cabotegravir, which requires more frequent dosing: two initial injections four weeks apart, followed by injections every two months. By contrast, Lenacapavir is administered only twice a year, making it a more convenient alternative for individuals who struggle with daily pills or frequent clinic visits.