GSK's HIV prevention drug gets the EU green light

Pharmaceutical giant GSK has announced that its Apretude drug for HIV prevention has received approval from the European Commission.

ViiV Healthcare, a specialist HIV company co-owned by GSK, Pfizer and Shionogi (GSK is the majority shareholder), showed in a clinical trial that Apretude demonstrated "superior efficacy" to the standard oral PrEP option in reducing the risk of acquiring HIV, which affects 100,000 newly diagnosed people each year in Europe.

"Cabotegravir is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35 kg," GSK said in a statement.

Apretude is given in a long-acting injectable and tablet form as few as six times a year, compared with the conventional method of daily pills. It is the first and only HIV prevention option of its kind in the EU.

Commenting on the news, ViiV Healthcare's chief executive 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".