Business Wire

Janssen Announces European Commission Approval of JULUCA®▼ (dolutegravir/rilpivirine), the First Two-Drug Regimen, Once-Daily, Single-Pill for the Treatment of HIV-1

Jaa

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission has granted marketing authorisation for JULUCA® (dolutegravir 50mg [ViiV Healthcare]/rilpivirine 25mg [Janssen Sciences Ireland UC]).1 ViiV Healthcare, as the marketing authorisation holder, will market dolutegravir/rilpivirine in all countries in the European Union and European Economic Area.

Dolutegravir/rilpivirine is the first two-drug regimen, once-daily, single-pill for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor (INI).1

“The European Commission Decision for dolutegravir/rilpivirine marks a significant milestone in our 25-year commitment to make HIV history,” said Brian Woodfall, VP, Global Head Late Development, Infectious Diseases, Janssen Research & Development, LLC. “At Janssen, the driving force behind our R&D efforts is to advance science and to discover and develop transformational medicines that advance health for humanity. We are proud to be combining our internal science with that of others to ensure optimised and individualised treatment options are available for those living with HIV-1.”

Dolutegravir/rilpivirine combines just two antiretrovirals in a single-pill regimen, reducing the cumulative drug exposure in people living with HIV-1, whilst maintaining the efficacy of traditional three-drug regimens at 48-weeks.2

“Dolutegravir/rilpivirine signifies an evolution in HIV-1 treatment options by combining two antiretrovirals into a once-daily, single-pill. It maintains the efficacy of a three-drug regimen but reduces the number of antiretrovirals, along with their potential toxicities, that virologically suppressed HIV-1 patients have to take and are therefore exposed to in the long-term,” said Dr. Josep M Llibre, Infectious Diseases Dept, University Hospital Germans Trias i Pujol, Badalona, Barcelona.

This approval brings another treatment option to the estimated 810,000 people living with HIV in Europe.3 It follows the Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) on 22 March 2018.4 Dolutegravir/rilpivirine was approved by the US Food and Drug Administration (FDA) in November 20175 and Health Canada in May 2018.6

Data from two pivotal Phase 3 trials (SWORD-1 and SWORD-2) published in The Lancet,2 showed that the dolutegravir and rilpivirine regimen is non-inferior to three- and four-drug regimens in maintaining virologic suppression (HIV-1 RNA <50 c/mL) through 48-weeks in virologically supressed adults who are infected with HIV-1, in both pooled and individual analyses of these Phase 3 studies (dolutegravir+rilpivirine 486/513 [95%] current antiretroviral regimen (CAR) 485/511 [95%], [adjusted difference -0.2% (95% confidence interval: -3.0%, 2.5%), pooled analysis]). Participating adults had stable plasma HIV-1 RNA (viral load <50 copies/mL) for 6 months or longer at screening, with no major resistance association mutations to protease inhibitor, nucleoside reverse-transcriptase inhibitors (NRTI), NNRTI or INI. Virologic suppression rates were similar between treatment arms at 48 weeks.2

Adverse events were reported by 77% of participants in the dolutegravir+rilpivirine group and 71% in the CAR group. The most commonly reported adverse events were nasopharyngitis (10% dolutegravir+rilpivirine, 10% CAR) and headache (8% dolutegravir+rilpivirine, 5% CAR). Adverse events leading to discontinuation in the dolutegravir+rilpivirine group occurred in 3% of patients and 1% in the CAR group. The safety profiles for dolutegravir and rilpivirine in these studies were consistent with the product labelling for each medicine.2

Notes to editors

In June 2014, ViiV Healthcare and Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced a collaboration to investigate the potential of combining dolutegravir and rilpivirine in a single-pill in order to expand the treatment options available to people living with HIV-1.7

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com /emea. Follow us at @JanssenEMEA. Janssen Sciences Ireland UC and Janssen Research & Development, LLC are each part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

About HIV

HIV stands for the Human Immunodeficiency Virus. Unlike some other viruses, the human body cannot get rid of HIV, so once someone has HIV they have it for life. There is no cure for HIV, but effective treatment can control the virus so that people with HIV can enjoy healthy and productive lives.

HIV has largely become a chronic treatable disease with improved access to antiretroviral treatment. This has led to a 22% drop in global HIV mortality between 2009 and 2013,8 but more can be done for the estimated 36.7 million people living with HIV9 of which 160,000 were newly diagnosed in the European region alone in 2016.10

About dolutegravir/rilpivirine

Dolutegravir/rilpivirine was approved by the US Food and Drug Administration (FDA) on 21 November 20175 and Health Canada on 18 May 20186, as a complete regimen for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of dolutegravir/rilpivirine.5

Dolutegravir/rilpivirine is a two-drug regimen, single-pill that combines the INI dolutegravir (50mg), with the NNRTI rilpivirine (25mg) taken once-daily with food as a complete regimen for people living with HIV-1 who are virologically suppressed.1

Two essential steps in the HIV life cycle include reverse transcription – when the virus turns its RNA (ribonucleic acid) copy into DNA (deoxyribonucleic acid) – and integration – the moment when viral DNA becomes part of the host cell’s DNA. These processes require two enzymes called nucleoside reverse transcriptase and integrase. NNRTIs and INSTIs interfere with the action of these two enzymes to prevent the virus from replicating. This decrease in replication can lead to less virus being available to cause subsequent infection of uninfected cells.

ViiV Healthcare has also submitted regulatory marketing applications in other countries worldwide.

About the SWORD phase 3 programme for dolutegravir (Tivicay) 11 and rilpivirine (EDURANT ® ) 12

The SWORD phase 3 clinical trial programme evaluates the efficacy, safety, and tolerability of switching to dolutegravir plus rilpivirine from current integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or protease inhibitor (+2 NRTI)-based antiretroviral regimen in HIV-1-infected adults who are virologically suppressed with a three or four-drug regimen. SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797) are replicate 148-week, randomised, open-label, non-inferiority studies to assess the antiviral activity and safety of a two-drug, once-daily oral regimen of dolutegravir plus rilpivirine compared with current antiretroviral therapy (full 148-week data will be shared in 2019). In the SWORD clinical trials, dolutegravir and rilpivirine are provided as individual tablets.2

The primary endpoint is the proportion of patients with plasma HIV-1 RNA <50 copies per millilitre (c/mL) at 48-weeks (intention to treat analysis). Key secondary endpoints include evaluation of the development of viral resistance, measurements of safety and tolerability, and changes in renal, bone and cardiovascular biomarkers. The studies also include exploratory measures to assess change in health-related quality of life, willingness to switch and adherence to treatment regimens.2

For more information on the trials please visit: www.clinicaltrials.gov

JULUCA ® and Tivicay (dolutegravir) 11 are trademarks owned by the ViiV Healthcare group of companies. It is important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at https://www.gsk.com/en-gb/contact-us/report-a-possible-side-effect/ . Adverse events should also be reported to GlaxoSmithKline 0800 221 441.

EDURANT ® (rilpivirine) 12 is a registered trademark of Janssen Sciences Ireland UC. It is important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447 or at dsafety@its.jnj.com .

Important Safety Information for dolutegravir/rilpivirine in the European Union: Please refer to the full European Summary of Product Characteristics.1

Cautions concerning forward-looking statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding potential approval, availability and benefits of a new treatment options for HIV-1. 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 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 behavior 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 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other 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 Dolutegravir/Rilpivirine European Commission approval details and the full Summary of Product Characteristics will be available on the European Medicines Agency website. [online] Available at: http://www.ema.europa.eu/ema/ [May 2018].
2 Llibre JM, Hung CC, Brinson C, et al. Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies. Lancet. 2018:391:839-849.
3 Pharris A, et al. Estimating HIV incidence and number of undiagnosed individuals living with HIV in the European Union/European Economic Area, 2015. Euro Surveill. 2016 Dec 1; 21(48): 30417.
4 Committee for Medicinal Products for Human Use (CHMP), European Medicines Agency Juluca Summary of Opinion, 2018. [online] Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004427/smops/Positive/human_smop_001278.jsp&mid=WC0b01ac058001d127 [Accessed May. 2018].
5 Johnson and Johnson. Janssen Announces U.S. FDA Approval of First and Only Complete, Single-Pill, Two-Drug Regimen, JULUCA® (Dolutegravir and Rilpivirine), for the Treatment of HIV-1 Infection. Press release November 21, 2017. [online] Available at: https://www.jnj.com/media-center/press-releases/janssen-announces-us-fda-approval-of-first-and-only-complete-single-pill-two-drug-regimen-juluca-dolutegravir-and-rilpivirine-for-the-treatment-of-hiv-1-infection [Accessed May. 2018].
6 Health Canada, Notice of Compliance and Product Monorgraph, “Juluca”, 2018. [Data on file]. [May. 2018].
7 Johnson and Johnson. Janssen Collaborates With ViiV Healthcare To Develop Two-Drug Single Tablet Regimen For The Maintenance Treatment Of People Living With HIV. Press release June 12, 2014. [online] Available at: https://www.jnj.com/media-center/press-releases/janssen-collaborates-with-viiv-healthcare-to-develop-two-drug-single-tablet-regimen-for-the-maintenance-treatment-of-people-living-with-hiv [Accessed May. 2018].
8 World Health Organization. Global update on the health sector response to HIV, 2014. [online] Available at: http://apps.who.int/iris/bitstream/10665/128494/1/9789241507585_eng.pdf?ua=1. [Accessed May. 2018].
9 UNAIDS. Fact sheet - Latest statistics on the status of the AIDS epidemic. [online] Available at: http://www.unaids.org/en/resources/fact-sheet [Accessed May. 2018].
10 World Health Organization. Infographic - newly diagnosed HIV infections in the WHO European Region, 2016. [online] Available at: http://www.euro.who.int/en/health-topics/communicable-diseases/hivaids/data-and-statistics/infographic-newly-diagnosed-hiv-infections-in-the-who-european-region,-2016 [Accessed May. 2018].
11 European Medicines Agency. Tivicay, 2014. [online] Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002753/WC500160680.pdf [Accessed May. 2018].
12 European Medicines Agency. Edurant, 2011. [online] Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002264/WC500118874.pdf [Accessed May. 2018].

Contact information

Janssen
Inès Hammer
Mobile: +33 688 093 335
or
Katie Buckley
Mobile: +44 7971 956 179

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 14:00Tiedote

Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines

Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 11:10Tiedote

Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months). “Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest

Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 18:13Tiedote

Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,

Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 17:00Tiedote

Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With

Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 16:41Tiedote

Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel

Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 15:00Tiedote

Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme