SIGNIFICANT MILESTONE FOR HIV PREVENTION IN SUB-SAHARAN AFRICA AS SOUTH AFRICA GRANTS REGULATORY APPROVAL FOR APRETUDE
We are extremely pleased to share the news that, the South African Health Products Regulatory Authority (SAHPRA) has granted regulatory approval of Apretude (cabotegravir long-acting injectable), the first and only long-acting option for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1.
Approval of cabotegravir long-acting for PrEP in South Africa was supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV. South Africa was the only country to take part in both studies. Regulatory submissions are currently underway in the other countries that took part in the HPTN083 and 084 studies.
South Africa bears the greatest burden of HIV worldwide and this is felt most significantly by women and young girls, where challenges with adherence, and stigma have hindered the potential impact of current PrEP are actively working with global partners to make Apretude an available prevention option for those who could benefit from PrEP. Following approval in South Africa, we look forward to seeing continued progress to help enable access.
Cabotegravir long-acting for PrEP is currently approved in the US, Australia, Zimbabwe and South Africa as Apretude. For more information on submissions around the world, please visit our website.
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