JANSSEN
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.
##END##
About ATLAS (NCT02951052)
ATLAS is a Phase 3, open-label, active-controlled, multi-centre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of LA, injectable rilpivirine and cabotegravir dosed every four weeks compared to continuation of current oral anti-retroviral therapy (ART) of two nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI) among virally suppressed individuals.7
The primary endpoint for ATLAS is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (missing, switch, or discontinuation = failure, intent-to-treat exposed [ITT-E] population). Participants were required to be virally suppressed for six months or longer, on a first or second regimen, with no prior failure.7
About ATLAS-2M (NCT03299049)
The ATLAS-2M study is a Phase 3, randomised, open-label, active-controlled, multicentre, parallel-group, non-inferiority study designed to assess the non-inferior antiviral activity and safety of long-acting rilpivirine and cabotegravir administered every eight weeks compared to long-acting rilpivirine and cabotegravir administered every four weeks over a 48-week treatment period in 1,045 adults living with HIV-1.8
Participants were required to be virologically suppressed for six months or greater, on first or second regimen, with no prior failure. The primary outcome measure for the study is the proportion of participants with HIV-1 RNA ≥50c/mL at Week 48 using the FDA Snapshot algorithm (Intent-to-Treat Exposed [ITT-E] population).1,8
ATLAS-2M is being conducted at research centres in Argentina, Australia, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States.
For further information, please see https://clinicaltrials.gov/ct2/show/NCT03299049 .
About FLAIR (NCT02938520)
FLAIR is a Phase 3, randomised, open-label, multi-centre, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of a two-drug regimen of intramuscular, long-acting injectable rilpivirine and cabotegravir in virologically suppressed adults living with HIV, following 20 weeks of induction therapy with ViiV Healthcare’s Triumeq®
(abacavir / dolutegravir / lamivudine) compared to continuation of the oral dolutegravir-based treatment regimen.9
The primary endpoint for FLAIR is the proportion of participants with plasma HIV-1 RNA ≥50 c/mL per the FDA Snapshot algorithm at Week 48 (missing, switch, or discontinuation = failure, intent-to-treat exposed [ITT-E] population).9
About rilpivirine and rilpivirine long-acting
The oral formulation of rilpivirine is also licensed for the treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-naïve patients 12 years of age and older and weighing at least 35 kg with a viral load ≤ 100,000 HIV RNA copies/mL.10
Rilpivirine long-acting is a prolonged-release suspension for IM injection developed by Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying. The EC marketing authorisation marks the second for the long-acting regimen of rilpivirine and cabotegravir with once-monthly dosing licensed by Health Canada under the brand name CABENUVA® for the treatment of HIV-1 infection in adults who are virologically stable and suppressed.11
Administration and dosing of rilpivirine and cabotegravir
Rilpivirine injection used in combination with cabotegravir injection will be the first complete long-acting regimen dosed once-monthly or once every 2-months, for virologically suppressed people living with HIV-1. Rilpivirine and cabotegravir injections are administered as two intramuscular (IM) injections in the buttocks by a Healthcare Professional at the same appointment. Prior to the initiation of the injections, rilpivirine and cabotegravir oral tablets are taken for approximately one month (at least 28 days) to assess tolerability to the medicines.
About cabotegravir
Cabotegravir is an INI developed by ViiV Healthcare for the treatment of HIV-1 in virologically suppressed adults. It is being evaluated in combination with injectable rilpivirine as a long-acting formulation.12
Integrase strand transfer inhibitors (INSTIs), like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection.
Important Safety Information (ISI)
Please refer to the full Summary of Product Characteristics for full prescribing
information for EDURANT®
(rilpivirine): https://www.medicines.org.uk/emc/product/4968/smpc
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com/emea
. Follow us at www.twitter.com/janssenEMEA
for our latest news. Janssen-Cilag International NV, Janssen Research & Development, LLC and Janssen Sciences Ireland Unlimited Company are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV and Janssen Research & Development, LLC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained
by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov
, www.jnj.com
or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
References
1
Swindells S, Andrade-Villanueva J-F, Richmond G, et al. Long-acting cabotegravir and rilpivirine for maintenance of HIV-1 suppression. N Engl J Med. DOI: 10.1056/ NEJMoa1904398.
2
European Medicines Agency. Rekambys Summary of Opinion.
3
De los Rios, P., Okoli, C., Young, B., Allan, B., Castellanos, E., Brough, G., Eremin, A., Corbelli, G. M., Hardy, W. D., and Van de Velde, N. (2020). Treatment aspirations and attitudes towards innovative medications among people living with HIV in 25 countries. Population Medicine, 2(July), 23. https://doi.org/10.18332/popmed/124781.
4
De Los Rios P, Okoli C, Castellanos C et al. Physical, Emotional and Psychosocial Challenges Associated with Daily Dosing of HIV Medications and Their Impact on Indicators of Quality of Life: Findings from the Positive Perspectives Study. AIDS and Behavior. 2020.
5
Orkin C, Arasteh K, Hernandez-Mora MG, et al. Long-acting cabotegravir and rilpivirine after oral induction for HIV-1 infection. N Engl J Med. DOI: 10.1056/ NEJMoa1909512.
6
Overton ET et. al. Cabotegravir and rilpivirine every 2 months is non inferior to monthly: ATLAS-2M study. Presented at CROI 2020: Available at: https://www.croiconference.org/abstract/cabotegravir-rilpivirine-every-2-months-is-noninferior-to-monthly-atlas-2m-study/
Last accessed December 2020.
7
Swindells S et al. (2019) Long-Acting Cabotegravir + Rilpivirine For Maintenance Therapy: Atlas Week 48 Results. Oral presentation, the Annual Conference on Retroviruses and Opportunistic Infections (CROI).
8
Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03299049
. Last accessed December 2020.
9
Orkin C et al. (2019) Long-Acting Cabotegravir + Rilpivirine For Hiv Maintenance: Flair Week 48 Results. Oral Presentation at the Annual Conference on Retroviruses and Opportunistic Infections (CROI).
10
EDURANT® Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/4968/smpc
Last accessed December 2020.
11
Drugs. Cabenuva FDA Approval Status. Available at: . Last accessed December 2020.
12
European Medicines Agency. Summary of opinion (Rekambys). Available at: https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-rekambys_en.pdf
Last accessed December 2020.
CP-197548
Date of preparation: December 2020
View source version on businesswire.com: https://www.businesswire.com/news/home/20201220005001/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SCENTMATIC's AI "KAORIUM" Debuts at THAMEEN Fragrance Launch in London's Selfridges4.7.2025 11:13:00 CEST | Press release
SCENTMATIC Inc., a leader in scent digitalization, introduced its AI-powered scent-to-language system, KAORIUM, at the THAMEEN Fragrance new product launch event. This pivotal event took place from June 5 to 11, 2025, at Selfridges department store in London, UK. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250703662207/en/ State of exhibition Global Expansion: KAORIUM Establishes UK Presence Europe leads the global fragrance market, with the UK projected to reach US$2.82 billion by 2033. Recognizing this, SCENTMATIC is rapidly expanding its international footprint. In May 2024, SCENTMATIC established its overseas subsidiary, KAORIUM, in London, appointing industry expert Ben Yanoushek as CEO. Official UK operations commenced on February 1, 2025, with the launch of its dedicated website: www.kaorium.com. KAORIUM Trialed at "Florentine Diamond" Launch Event The "Florentine Diamond" launch event for luxury brand THAMEEN Frag
Andersen Consulting samarbejder med Mercurial Minds om at forbedre mulighederne inden for digital transformation4.7.2025 01:10:00 CEST | Pressemeddelelse
Andersen Consulting udvider sit udbud af teknologidrevne løsninger med tilføjelsen af samarbejdsfirmaet Mercurial Minds (M.M.), et konsulentfirma inden for digital transformation, AI og IT med base i Pakistan. M.M. blev grundlagt i 2013 og tilbyder en række tjenester, der er designet til at hjælpe organisationer med at udvikle sig og skalere, herunder i forbindelse med deres digitale transformationsstrategi, AI-tjenester, it-rådgivning og udvikling af robuste mobil- og webbrugeroplevelser. Firmaet leverer end-to-end-løsninger – udformning af datadrevne køreplaner, udvikling af intelligent automatisering og levering af sikre mobil- og weboplevelser, der kan skaleres – skræddersyet til virksomheder, der ønsker at forbedre sine forbindelsesmulighederne og opnå indsigter i realtid. M.M. betjener en bred vifte af brancher med fokus på finans, telekommunikation og andre dataintensive sektorer. "Dette samarbejde er en katalysator," siger Nabeel Saiyer, administrerende direktør for M.M. "Vores
Global Tourism Surging Ahead of Economic Growth, With Visits to Hit 30 Billion by 20344.7.2025 01:00:00 CEST | Press release
The World Economic Forum report, in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, predicts a significant uptick in tourist trips across the globeThe tourism sector will contribute $16 trillion to global GDP (more than 11% of the global economy) by 2034, according to World Travel & Tourism Council estimates (WTTC)India and China will be responsible for more than 25% of all outbound travel by 2030 The World Economic Forum has today published a new report forecasting that the travel and tourism industry is projected to serve 30 billion tourist trips by 2034. Travel and Tourism at a Turning Point: Principles for Transformative Growth, produced in collaboration with Kearney and the Ministry of Tourism Saudi Arabia, reveals a projected $16 trillion contribution to global GDP by the same year—representing more than 11% of the total world economy, according to World Travel & Tourism Council estimates. The report also found that the sector is expanding 1.5 times faster th
The 2025-2026 World Branding Awards Animalis Edition Honouring Leading Pet and Animal Brands Globally3.7.2025 21:00:00 CEST | Press release
The 2025-2026 World Branding Awards Animalis Edition marked its fifth instalment, bringing together leading pet and animal brands from all around the world. These brands were celebrated for their outstanding achievements, earning recognition as National, Regional, and Global Winners. The awards ceremony, held at Vienna's prestigious Hofburg Palace, welcomed winners across diverse categories, including pet food, retail, wellness, pet exhibitions, and aquatic products. Mounia Berrada-Gouzi expertly hosted the evening, which culminated in a grand celebration of brand excellence. “The Animalis Edition of the World Branding Awards recognises brands that have achieved the highest distinction—genuine recognition in the hearts and minds of consumers. Tonight, we honour those whose names resonate globally, whose values inspire loyalty, and whose presence defines excellence in the pet and animal industry,” said Richard Rowles, Chairman of the World Branding Forum. Out of over 950 brands nominate
Venture Global Announces 20-Year Sales and Purchase Agreement with PETRONAS3.7.2025 14:59:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) announced the execution of a new 20-year Sales and Purchase Agreement (SPA) with PETRONAS LNG Ltd. (PLL), a subsidiary of the Malaysian state-owned oil and gas company, PETRONAS. Under the terms of the SPA, PETRONAS will purchase 1 million tonnes per annum (MTPA) of liquefied natural gas (LNG) from Venture Global’s third facility, CP2 LNG, for 20 years. This builds upon Venture Global’s existing agreement with PETRONAS for 1 MTPA of LNG supply from Plaquemines LNG. PETRONAS, a world-class partner in the LNG industry, joins other CP2 LNG customers in Europe, Asia and the rest of the world in a strategically important project to global energy supply and security. To date, approximately 10.75 MTPA of the 14.4 MTPA nameplate capacity for CP2 Phase One has been sold. About Venture Global Venture Global is a long-term, low-cost provider of U.S. LNG sourced from resource rich North American natural gas basins. Venture Global’s business includes assets ac
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom