Cabotegravir is indicated for use in high-risk adults and adolescents aged a minimum of 12 years weighing at least 35 kg.
It is claimed to be the first and only HIV prevention therapy approved in the European Union (EU) that minimises the number of doses from 365 daily pills to a minimum of six injections annually.
ViiV Healthcare CEO Deborah Waterhouse said: “This authorisation marks a pivotal milestone for people across the EU who could benefit from an innovative, long-acting HIV prevention option that may better suit their personal preferences.
“Long-acting PrEP, alongside other HIV prevention strategies, plays an important role in helping to address some of the challenges that people may have with oral PrEP options.”
The approval is based on results from the global, active controlled, multicentre, randomised, double-blind HPTN 083 and HPTN 084 Phase IIb/III studies.
These studies evaluated the efficacy and safety of cabotegravir LA for PrEP in HIV-negative men who had sex with men, cisgender women and transgender women who were at high risk of HIV.
They compared patients receiving daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) 200 mg/300 mg tablets against cabotegravir given every eight weeks.
Cabotegravir LA for PrEP demonstrated to be superior against the daily oral FTC/TDF tablets with lower rate of HIV acquisition.
It is also approved for use in Australia, South Africa, the US, and several other countries as Apretude.
Submission for approval of Cabotegravir LA to other regulatory agencies is also underway.
Cabotegravir is an integrase strand transfer inhibitor that inhibits replication of HIV by preventing the viral DNA from integrating into the genetic material of human T-cells.