South Africa has approved Lenacapavir, a new antiviral medicine for pre-exposure prophylaxis (PrEP) to prevent HIV-1 infection, hailed by the World Health Organisation (WHO) as a potential game-changer for the country’s epidemic.
The South African Health Products Regulatory Authority (SAHPRA) approved Lenacapavir for adults and adolescents weighing at least 35 kg. The medicine is administered as a six-monthly injection, starting with a subcutaneous initiation dose supported by tablets on days one and two.
WHO Director-General Tedros Adhanom Ghebreyesus praised South Africa’s swift approval on social media, stating:
“Congratulations, South Africa, on your rapid action to register the use of lenacapavir for prevention of HIV, a potential game-changer for the epidemic in your country.”
The application for Lenacapavir was submitted by Gilead in March 2025 and reviewed through the European Medicines for All Procedure (EU-M4all), a process that allows the European Medicines Agency and participating regulatory authorities to provide scientific opinions on high-priority medicines for markets outside the EU.
SAHPRA emphasized that the pathway strengthens regulatory systems and accelerates access to essential medicines. Lenacapavir is intended for HIV-negative adults and adolescents at risk, but should always be used alongside safer sex practices, such as condom use, to reduce the risk of other sexually transmitted infections.