GSK PLC on Tuesday said the European Commission has authorised ViiV Healthcare’s ‘superior’ drug Apretude to reduce the risk of sexually acquired HIV-1 infection.

The London-based pharmaceutical manufacturer is the majority owner of ViiV Healthcare, a pharmaceutical firm specialising in HIV prevention and treatment. Pfizer Inc and Shionogi & Co Ltd are also shareholders.

GSK said ViiV’s cabotegravir long-acting injectible and tablets, brand name Apretude, is now the first and only HIV prevention option approved in the European Union which reduces the required dosage from one pill daily to ‘as few as’ six injections each year.

GSK said Apretude, in combination with safer sex practices for pre-exposure prophlaxis or PrEP, is indicated to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and children aged 12 years and over.

In clinical trials, GSK said Apretude has shown ‘superior efficacy’ in lowering the risk of HIV acquisition compared with daily oral emtricitabine/tenofovir disoproxil fumarate, the first antiretroviral drug developed for PrEP.

‘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,’ said ViiV Chief Executive Officer Deborah Waterhouse. ‘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.’

GSK shares were down 0.2% at 1,502.00 in London on Tuesday morning.

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