Janssen Announces European Commission Authorisation of the First Complete Long-Acting Injectable HIV Treatment in Europe

Marketing Authorisation granted by European Commission for Janssen’s REKAMBYS® (rilpivirine injection) to be used with ViiV Healthcare’s VOCABRIA® (cabotegravir injection and tablets)

Long-acting, two-drug regimen can enable reduction of treatment days from 365 to 12 or six per year after initiation

The long-acting injectable regimen was preferred by majority of clinical trial patients who tried the treatment over their previous daily oral therapy1

BEERSE, BELGIUM, 21 December, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the authorisation of REKAMBYS® (rilpivirine injection) in combination with ViiV Healthcare’s VOCABRIA® (cabotegravir injection and tablets) in the European Union for the treatment of HIV-1 infection in adults who are virologically suppressed.2 This authorisation represents the first-time people living in Europe with HIV may be able to receive a long-acting injectable treatment that removes the need to take daily oral tablets.

“There has been significant progress in the way HIV is managed and perceived over the past 30 years. However, for many people living with or at risk of HIV, stigma and discrimination remains and often prevents them from speaking out or seeking treatment,” said Professor Giovanni Guaraldi*, Associate Professor of Infectious Disease and Head of the Modena HIV Metabolic Clinic (MHMC), Italy. “This long-acting regimen could mean people living with HIV no longer need daily therapy, maintaining viral load suppression with just 12 or six injection days a year and eliminating a daily reminder of their condition. My hope is that, as medicines continue to improve, they will lead to further significant developments, particularly for some of those who still face discrimination.”

Underscoring the need for a less frequent dosing regimen, the largest global HIV patient-reported outcomes study to-date conducted by ViiV Healthcare, Positive Perspectives Wave 2, found that when participants were asked about their treatment aspirations and attitudes towards innovative medications

, 55 percent (n=1306/2389) would prefer a long-acting regimen.3 In addition, 58 percent (n=1394/2389) noted that taking daily HIV medication acts as a constant reminder of HIV in their lives, while up to 38 percent (n=906/2389) of participants reported anxiety around the fact that taking daily treatment could increase the chances of revealing their HIV status to others.4

“We are delighted with the European Commission’s decision to approve this long-acting injectable treatment,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee, Chief Scientific Officer, Johnson & Johnson. “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.”

Marketing Authorisation is based on the pivotal Phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression), FLAIR (First Long-Acting Injectable Regimen) and ATLAS-2M studies, which included more than 1,200 participants from 16 countries.1,5,6 The rilpivirine and cabotegravir injection combination is indicated for adults who are virologically suppressed (HIV-1 RNA less than 50 copies/mL), on a stable antiretroviral regimen, without present or past evidence of viral resistance to, or virological failure with, agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) classes.

Janssen’s long-acting rilpivirine in combination with ViiV Healthcare’s long-acting cabotegravir was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s industry-leading portfolio that is centered on delivering innovative medicines for the HIV community.

*Professor Giovanni Guaraldi is a paid consultant for Janssen. He has not been compensated for any media work.