Therapy Areas: AIDS & HIV
European Commission grants authorisation to ViiV Healthcare's Apretude for prevention of HIV
19 September 2023 -

Biopharmaceutical company GSK plc (LSE/NYSE: GSK) announced on Wednesday that ViiV Healthcare, a global specialist HIV company primarily owned by GSK, with Pfizer and Shionogi as shareholders, has received European Commission (EC) approval for Apretude (cabotegravir long-acting (LA) injectable and tablets) for HIV prevention. Cabotegravir is indicated for high-risk adults and adolescents (at least 12 years old) weighing at least 35 kg, in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection.

Apretude offers a unique HIV prevention option in the European Union (EU), reducing the dosing frequency from 365 daily pills to as few as six injections per year, surpassing daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in efficacy, providing more choices for PrEP.

The approval is supported by data from HPTN 083 and HPTN 084 studies, demonstrating cabotegravir LA's superiority over FTC/TDF tablets in preventing HIV acquisition. Cabotegravir LA for PrEP is also approved in the US, Australia, South Africa and other countries under the name Apretude.

Cabotegravir long-acting for HIV prevention is an integrase strand transfer inhibitor (INSTI) administered as an injection every two months. It offers an alternative to daily oral PrEP options and is undergoing evaluation for additional indications.

ViiV Healthcare, established in 2009, focuses on advancing HIV treatment and care, with support from GSK, Pfizer, and Shionogi. GSK aims to harness science, technology and talent to combat diseases globally.