The European Commission (EC) has authorised Janssen’s Rekambys (rilpivirine injection) in combination with ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to treat HIV-1 infections in adults who are virologically suppressed.
This approval marks the first time that people living in the EU with HIV can receive a long-acting injectable treatment without having to take daily oral tablets, Janssen said in a statement.
The marketing authorisation is based on the phase III ATLAS, FLAIR and ATLAS-2M studies, which includes over 1,200 participants from 16 countries.
“At Janssen, we are incredibly proud of this authorisation and the progress it marks in achieving our goal to address some of the biggest health threats of our time. We will continue building on our 25-year commitment to make HIV history and to change the course of the epidemic through our passionate pursuit of innovation, from long-term remission to effective prevention of HIV,” said Paul Stoffels, vice chairman of the executive committee, chief scientific officer, Johnson & Johnson.
“At ViiV Healthcare, we push the boundaries to provide new treatment options that will help make a difference to people’s lives. We saw from the patient reported outcomes in our pivotal clinical trials that approximately nine out of ten people who switched to the long-acting regimen preferred this over their previous daily oral tablets,” said Deborah Waterhouse, chief executive officer of ViiV Healthcare.
A study conducted by ViiV Healthcare – the Positive Perspectives Wave 2 study – found that when participants were asked about their treatment aspirations and attitudes towards innovative medications, 55% said they would prefer not to take medication every day as long as their HIV remains suppressed.