Janssen Seeks to Expand Use of TREMFYA®▼ (guselkumab) in the Treatment of Adults With Active Psoriatic Arthritis
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Type II Variation Application to the European Medicines Agency (EMA) seeking first-in-class approval of TREMFYA® ▼(guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA). If approved, this will be the second approved indication for guselkumab in the European Union.
Guselkumab is a human monoclonal antibody against the p19 subunit of interleukin (IL)-23, which is an important driver of the pathogenesis of immune-mediated inflammatory diseases such as psoriasis and PsA.1,2
It is estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also develop PsA, a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.3,4,5 The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any age.6
“This submission to the EMA is an important milestone for people with psoriatic arthritis, who currently have limited treatment options that improve the signs and symptoms of the condition,” said Alyssa Johnsen, M.D. Ph.D., Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. “With this filing, we hope to offer clinicians a new and innovative treatment option for people living with psoriatic arthritis.”
This regulatory submission is based on data from the Phase 3 DISCOVER-1 and DISCOVER-2 studies. The DISCOVER programme comprises the first-ever Phase 3 studies evaluating a human monoclonal antibody targeting the p19 subunit of IL-23 in patients with active PsA, and the results have been submitted for presentation at an upcoming medical meeting.
“Psoriatic arthritis is a complex disease causing considerable distress to those afflicted and their families. It is believed to be caused by both genetic and environmental factors,” said Professor Iain McInnes,* Muirhead Professor of Medicine and Director of the Institute of Infection Immunity and Inflammation, University of Glasgow. “Although treatment options for PsA have improved dramatically over the past 15 years, a significant unmet need still exists, with only half of patients achieving more than a 20 percent improvement in joint symptoms in randomised clinical trials. Moreover, too few patients enjoy an acceptable quality of life. New treatment options with different mechanisms of action are urgently needed to improve outcomes.”
Guselkumab was previously approved in the European Union for the treatment of adult patients with moderate to severe plaque psoriasis in November 2017 and has also been approved in the U.S., Canada, Japan and several other countries worldwide.
In the phase 2a study of guselkumab in PsA, guselkumab was generally well tolerated during approximately 1 year of exposure.7 The incidence of adverse events, including infections, was similar across both treatment groups. Few serious adverse events were reported, discontinuation was infrequent, and serious infections were rare. The safety outcomes in this phase 2a study were generally consistent with those observed in clinical trials investigating guselkumab in psoriasis.8,9
During clinical development of guselkumab in psoriasis, guselkumab was generally well-tolerated.8,9,10,11 The very common and common adverse events associated with guselkumab are as follows: upper respiratory infection (very common, ≥1/10), and arthralgia, diarrhoea, gastroenteritis, headache, herpes simplex infections, injection site erythema, tinea infections and urticaria (common, ≥1/100 to <1/10). Injection site pain, hypersensitivity and rash have been reported as uncommon adverse events (≥1/1,000 to <1/100).2
*Professor Iain McInnes is a paid consultant for Janssen. He has not been compensated for any media work.
About psoriatic arthritis
Psoriatic arthritis is a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.5 The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time.6 Although the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in disease onset.3,5,12
About the DISCOVER trial programmes
Both DISCOVER trials are randomised, double-blind, multicentre Phase 3 studies designed to evaluate the efficacy and safety of TREMFYA administered by subcutaneous injection in patients with active PsA compared to placebo. DISCOVER-1 evaluates 381 participants, including those previously treated with anti-TNF therapy, and is planned to continue through approximately 1 year. DISCOVER-2 includes 739 biologic-naïve participants and is planned to continue through approximately 2 years. The data from both the DISCOVER trials have been submitted for presentation at an upcoming medical meeting.
About TREMFYA® (guselkumab)
Developed by Janssen, guselkumab is a human monoclonal antibody against the p19 subunit of IL-23.2 Guselkumab was granted marketing authorisation in the European Union and is approved in the U.S., Canada, Japan and several other countries worldwide for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy). IL-23 is an important driver of the pathogenesis of inflammatory diseases such as psoriasis and psoriatic arthritis.1 The guselkumab development programme includes two Phase 3 programmes evaluating TREMFYA in the treatment of active psoriatic arthritis.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to guselkumab.
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.
Janssen-Cilag International NV, the marketing authorization holder for TREMFYA© in the EU, and Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the submission of a Group Type II Variation Application to the European Medicines Agency (EMA) seeking approval of TREMFYA® (guselkumab) for the treatment of adult patients with active psoriatic arthritis (PsA). 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, 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 30, 2018, 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.
1 Hueber and McInnes (2007) Immune regulation in psoriasis and psoriatic arthritis--recent developments. Immunol Lett;114:59–65
2 European Medicines Agency. Tremfya Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf. Last accessed October 2019.
3 Ogdie A et al. The Epidemiology Psoriatic Arthritis. Rheum Dis Clin North Am. 41(4) 545-568. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4610151/pdf/nihms-710337.pdf. Last accessed October 2019.
4 Ortonne J.P. et al. (2004) Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. European Journal of Dermatology;14:41–45.
5 Versus Arthritis. Psoriatic Arthritis. Available at: https://www.versusarthritis.org/about-arthritis/conditions/psoriatic-arthritis/. Last accessed October 2019.
6 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: https://www.psoriasis.org/about-psoriatic-arthritis. Last accessed October 2019.
7 Deodhar A, et al. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Lancet 2018; 391:2213-24.
8 Reich K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the Phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial . J Am Acad Dermatol 2017;76(3):418–31.
9 Blauvelt A, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017;76(3):405–17.
10 Reich K, et al. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet 2019; 394(10201):831–39.
11 Langley R, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol 2017;178(1):114–23.
12 Gladman D.D et al (2005) Psoriatic arthritis: epidemiology, clinical features, course and outcome. Ann Rheum Dis;64(Suppl II):ii14–ii17.
13 Deodhar A et al. (2019) Guselkumab, an Anti-interleukin-23p19 Monoclonal Antibody, in Patients with Active Psoriatic Arthritis Who Were Biologic-Naïve or Prior TNFα Inhibitor-Treated: Week 24 Results of a Phase 3, Randomized, Double-blind, Placebo-controlled Study. Available at: https://acrabstracts.org/abstract/guselkumab-an-anti-interleukin-23p19-monoclonal-antibody-in-patients-with-active-psoriatic-arthritis-who-were-biologic-naive-or-prior-tnf%ce%b1-inhibitor-treated-week-24-results-of-a-phase-3-rando/. Last accessed October 2019.
14 Clinicaltrials.gov. A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03158285?term=NCT03158285&rank=1. Last accessed October 2019.
+316 1526 8214
+1 732 524 2955
+1 732 524 3922
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
A Better Alternative to Banking - ClubSwan.com27.1.2020 12:00:00 EET | Press release
ClubSwan.com, the leader in membership driven financial solutions, further expands its innovative alternative banking capabilities to key global markets. As traditional financial institutions continually struggle to provide innovative and meaningful ways to bring value to individual and corporate customers and as digital assets/crypto currencies are experiencing global growth, ClubSwan.com continues to evolve to meet the efficiencies and demands that these new assets and our customers require and to which traditional banks have no answer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200127005046/en/ Instead, closed bank accounts, rejected transactions, crippling delays with customers receiving their funds (if at all) are all the norm with traditional banks. To add to this dilemma, the availability of trustworthy solutions where customers have peace of mind for both crypto assets and traditional currencies have been non-exi
GSMA Recognizes Turkcell and P.I. Works for the Value of AI Based Network Automation27.1.2020 10:00:00 EET | Press release
Turkcell and P.I. Works have been recognized by GSMA Future Networks Programme for achieving exceptional efficiency gains in network operations and ensuring superior customer experience. P.I. Works and Turkcell have successfully shown that the AI based, service aware network automation delivered stronger improvements as compared to conventional automation solutions. The details of the deployed solutions and their benefits are provided in a joint white paper authored by GSMA, Turkcell and P.I. Works under GSMA’s Future Networks Programme. To read the white paper please visit: https://www.gsma.com/futurenetworks/wiki/case-study-ai-use-cases-in-service-assurance/ GSMA Future Networks Programme intends to help operators share best practices and discover new opportunities that will enable them to reduce operational and capital expenditures. Given the success of the project, GSMA invited Turkcell and P.I. Works to join the program and provide insights for the AI-based, Service Aware Automate
Phase 2 DESTINY-Gastric01 Trial of DS-8201 Versus Chemotherapy Met Primary Endpoint27.1.2020 10:00:00 EET | Press release
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced positive topline results from the pivotal phase 2 DESTINY-Gastric01 trial of DS-8201, a HER2 directed antibody drug conjugate (ADC), in patients with HER2 positive unresectable or metastatic gastric or gastroesophageal junction cancer that had progressed following two or more treatment regimens including trastuzumab and chemotherapy. The trial met its primary endpoint, achieving a statistically significant and clinically meaningful improvement in objective response rate (ORR), as assessed by an independent review committee, in patients treated with DS-8201 versus investigator’s choice of chemotherapy (irinotecan or paclitaxel monotherapy). DS-8201 also showed a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint. The safety profile observed for DS-8201 in DESTINY-Gastric01 was consistent with previous clinical trials. These results c
HighRes Biosolutions and Novo Nordisk partner to transform drug discovery in automated Lab of the Future24.1.2020 17:00:00 EET | Press release
HighRes Biosolutions and Novo Nordisk A/S today announced that they will collaborate to design a state-of-the-art robotic platform for high-throughput biologics engineering and characterisation. The integration of a multi-system robotics platform with sophisticated software control architecture will enable a digital transformation and accelerated discovery for Novo Nordisk’s peptide and large molecule therapeutics research. “In order to maintain our leadership within biologics engineering we are investing in a fully automated and digital design platform. This investment is linked to our build-up in AI and advanced analytics and demonstrates Novo Nordisk’s commitment as a world leading biologics research company,” said Lars Fogh Iversen, senior vice president, Global Research Technologies, Novo Nordisk. The platform will comprise several highly automated and integrated cells for production, characterisation and functional analysis of thousands of biologic compounds every month. Its scop
Conquest Invests in 5 Greenfield Onshore Wind Parks Totalizing 43MW in the Flanders Region24.1.2020 15:37:00 EET | Press release
Conquest, acting through the Conquest Sustainable Infrastructure fund, announced the transaction was closed after an exclusive agreement had been reached with ENGIE Electrabel. Conquest acquires 51% of a portfolio expected to provide 111 GWh per annum of renewable power representing the annual electricity consumption of about 32,000 Belgian homes from early 2021 onwards. The projects benefit from 15 to 20-year green certificates local remuneration schemes, and thus generate yearly secured revenues. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005221/en/ Credit: Electrabel While the energy and digital transitions continue to drive the infrastructure sector, Conquest keeps building its diversified sustainable real asset portfolio in Western European markets. The success lies in years of collaboration and long-lasting partnerships with fellow industry experts who can notably facilitate access to new growth opportunities
Fluence Expands EMEA Footprint with Horticulture Partners in Papenburg, Germany24.1.2020 14:00:00 EET | Press release
Fluence by OSRAM (Fluence), a leading global provider of energy-efficient LED lighting solutions for commercial cannabis and agriculture production, announced today it is expanding its presence in the Emsland region of Germany through partnerships with growers and other horticulture specialists operating out of Papenburg. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200124005109/en/ Friedrich Schulz’s 5.5 hectare farm—which grows herbs year-round in addition to lettuce, peppers and chives—utilizing VYPR 2p fixtures. (Photo: Business Wire) Given Papenburg’s decades-long history of attracting horticulture experts, Fluence’s innovative lighting solutions for horticulture are a natural fit for the region’s tomato, cucumber, leafy greens and herb growers. Forging connections with Papenburg’s horticultural leaders Elektro Evers, an engineering firm specializing in greenhouse technology, is Fluence’s exclusive systems integrator
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