European Commission approves PONVORY TM ▼ (ponesimod), a Once Daily, Oral Therapy for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis with Active Disease Defined by Clinical or Imaging Features
Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced today that the European Commission (EC) has approved PONVORY ▼(ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.4
“Relapsing multiple sclerosis is an unpredictable and complex disease that can present very differently from individual to individual, placing a heavy burden on the patient and their loved ones,” said Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Professor of Neurology at Queen Mary University of London. “I welcome the European Commission’s approval of ponesimod as an additional treatment option for those living with relapsing multiple sclerosis - it will provide patients with additional choice when making decisions about their treatment.”
The EC approval of ponesimod is based on data from the Phase 3 OPTIMUM trial,a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 adult patients (aged 18-55 years) in 28 countries.1 The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod (20mg) vs. once-daily teriflunomide (14mg), an approved and widely-used first-line oral treatment, in adult patients with RMS.1 The large, Phase 3 study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualised relapse rate (ARR), with a rate reduction of 30.5 percent (p<0.001) compared with teriflunomide.1 Ponesimod also showed statistically significant superiority on one of the secondary endpoints, combined unique active lesions (CUALs).1 Ponesimod significantly reduced the number of new inflammatory lesions on brain MRI by 56 percent (p<0.0001) at week 108 when compared to teriflunomide.1
“The OPTIMUM study is the first Phase 3 study establishing superiority versus another disease modifying treatment for relapsing multiple sclerosis, with ponesimod showing significant reductions in annual relapse rates versus teriflunomide, an active comparator and widely-used first-line oral treatment,” said Catherine Taylor, M.D., Vice President, Medical Affairs, Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Johnson & Johnson Middle East FZ-LLC. “The approval of ponesimod by the European Commission is a positive step for people living with relapsing multiple sclerosis, as we work to provide them with an additional treatment option to manage and control their condition.”
Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.1 The most commonly reported adverse events in either the ponesimod 20mg group versus the teriflunomide 14mg group were Alanine Aminotransferase (ALT) enzyme elevations (19.5% vs. 9.4%), nasopharyngitis (19.3% vs. 16.8%), headache (11.5% vs. 12.7%), upper respiratory tract infection (10.6% vs. 10.4%) and alopecia (3.2% vs. 12.7%).1 The safety profile of ponesimod is consistent with the known safety profile of other S1P receptor modulators, although a head-to-head comparison, other than with teriflunomide, is not available.
“At Janssen, our mission is to reduce the burden, disability and devastation caused by diverse diseases of the central nervous system, including multiple sclerosis, for which there remains significant unmet patient need,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “The approval of ponesimod by the European Commission is a significant milestone as it showcases our continued commitment in neurology, reflecting our deepened focus and commitment to this space.”
The EC approval follows the positive CHMP opinion for ponesimod in March 20215 and the announcement of the U.S. Food and Drug Administration (FDA) approval of ponesimod for use in adults with relapsing forms of MS.6 EC approval is valid in all 27 member states of the European Union, and the European Economic Area countries (Norway, Iceland and Liechtenstein).
*Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Professor of Neurology at Queen Mary, University of London is a paid consultant for Janssen. He did not receive any remuneration for his media work.
About Multiple Sclerosis
MS is a chronic autoimmune inflammatory disease of the central nervous system (CNS) in which immune cells attack myelin (the protective casing that insulates nerve cells), damaging or destroying it and causing inflammation.7 This affects how the CNS processes information and communicates with the rest of the body, causing the neurologic signs and symptoms of MS.8 Symptoms vary by person, but common symptoms include fatigue, balance and walking problems, numbness or tingling, dizziness and vertigo, vision problems, bladder and bowel problems and weakness.8,9,10
About PONVORY (ponesimod)
Ponesimod is an oral, highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.11 In patients with multiple sclerosis (MS), inflammatory immune cells, including lymphocytes, can cross the blood brain barrier into the brain and damage myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of MS.12
One of the Janssen Pharmaceutical Companies of Johnson & Johnson, Actelion Pharmaceuticals Ltd, is party to a revenue sharing agreement with Idorsia Pharmaceuticals Ltd, which provides for certain payments to Idorsia related to the sales of ponesimod.
▼ Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product.
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 Research & Development, LLC, and Johnson & Johnson Middle East FZ-LLC are 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 ponesimod. 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 Actelion Pharmaceuticals Ltd, Janssen Phamaceutica NV and/or 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 January 3, 2021, 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 Kappos L, Fox RJ, Burcklen M, et al. Ponesimod compared with teriflunomide in patients with relapsing multiple sclerosis in the active-comparator phase 3 OPTIMUM study: a Randomized clinical trial. JAMA Neurol. 2021.
2 Olsson T, Boster A, Fernández Ó, et al. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase ll trial. J Neurol Neurosurg Psych. 2014;85(11):1198208.
3 Freedman M, Pozzilli C, Havrdova EK, et al. Long-term Efficacy and Safety of Ponesimod: Results from Randomized Phase II Core and Extension Studies in Relapsing-Remitting Multiple Sclerosis. Presented at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. 2020.
4 European Medicines Agency. Ponesimod Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/medicines Last accessed: May 2021.
5 Johnson & Johnson. Janssen Receives Positive CHMP Opinion for PONVORY™ ▼ (ponesimod) for the Treatment of Adults With Relapsing Forms of Multiple Sclerosis With Active Disease Defined by Clinical or Imaging Features. Available at: https://www.janssen.com/janssen-receives-positive-chmp-opinion-ponvory-v-ponesimod-treatment-adults-relapsing-forms. Last accessed: May 2021.
6 Johnson & Johnson. Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio (teriflunomide) in Reducing Annual Relapses and Brain Lesions.Available at: https://www.jnj.com/janssen-announces-u-s-fda-approval-of-ponvory-ponesimod-an-oral-treatment-for-adults-with-relapsing-multiple-sclerosis-proven-superior-to-aubagio-teriflunomide-in-reducing-annual-relapses-and-brain-lesions Last accessed: May 2021.
7 National Multiple Sclerosis Society. Definition of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Definition-of-MS Last accessed: May 2021.
8 National Multiple Sclerosis Society. Symptoms and Diagnosis. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis Last accessed: May 2021.
9 Giovannoni G, Butzkueven H, Dhib-Jalbut S, et al. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016;9(1):5-48.
10 National Multiple Sclerosis Society. Cognitive Changes. Available at: https://www.nationalmssociety.org/Symptoms-Diagnosis/MSSymptoms/Cognitive-Changes Last accessed: May 2021.
11 D’Ambrosio D, Feedman MS, Prinz J. Ponesimod, a selective S1P1 receptor modulator: a potential treatment for multiple sclerosis and other immune-mediated diseases. Ther Adv Chron Dis. 2016;7:18-33.
12 Multiple Sclerosis Association of America. The immune system and multiple sclerosis. Available at: https://mymsaa.org/ms-information/overview/immune-system/ Last accessed: May 2021.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Dare to DeFi: DeFi Summit’s First-Ever Global Virtual Conference Brings Together Over 120 Top Industry Leaders14.6.2021 02:15:00 CEST | Press release
The largest-ever dedicated conference focused specifically on decentralized finance starts today at 9am Pacific Time. DeFi Summit is a weeklong virtual event bringing together the builders and developers that make up the decentralized finance and non-fungible token community. Free to attend, talks and presentations will be held on a broad range of topics, including DEX, wallets, DAOs, NFTs, insurance, lending, and many more. DeFi Summit 2021 Agenda: Day 1 (Monday, June 14) – The summit starts with a full day focused on NFTs. Notable speakers include digital artists Pplpleasr and Matty Mo, Max Moore of Sotheby’s, and companies including Axie Infinity, Animoca Brands and Aavegotchi. Day 2 (Tuesday, June 15) – A mystery billionaire investor is the special guestjoining Polygon Power Hour alongside Stani Kulechov from Aave, Sandeep Naiwal from Polygon and Roc Zacharias from Quickswap. Stay tuned for Coinbase, Unicrypt, Finance.Vote, and YFDAI, plus an exciting panel featuring OG DeFi VCs Le
Celltrion Healthcare presents the first real-world data for Truxima ® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress12.6.2021 17:45:00 CEST | Press release
Celltrion Healthcare today presented new data from its post-approval study evaluating the real-world clinical effectiveness and safety of Truxima® (biosimilar rituximab, CT-P10) in patients with diffuse large B-cell lymphoma (DLBCL) at the European Hematology Association (EHA) 2021 Virtual Congress.1 CT-P10 was granted European Medicines Agency approval in 2017 for the treatment of rheumatoid arthritis (RA) and specific blood cancers, including non-Hodgkin’s lymphoma (NHL).2 DLBCL is the most common subtype of NHL, representing an estimated 30-40% of adult cases.3,4,5,6 This non-interventional post-authorisation safety study (PASS) involved the collection of patient-level data from hospital medical records for patients with DLBCL who received CT-P10 treatment in five European countries (United Kingdom, Spain, France, Germany and Italy). CT-P10 treatment pattern data were collected retrospectively during the 30-month observation period and patients were selected based on the treatment t
Janssen Announces Results from Phase 3 MAIA Study Showing Significant Overall Survival Benefits for Treatment with DARZALEX ® ▼ (daratumumab) in Patients with Newly Diagnosed Multiple Myeloma Who are Transplant Ineligible12.6.2021 09:01:00 CEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® ▼(daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly diagnosed multiple myeloma (NDMM) who were ineligible for autologous stem cell transplant (ASCT) and were treated to progression.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing and will be presented as a late-breaking abstract during the EHA Virtual Congress (Abstract #LB1901). The prespecified interim analysis for OS found that after a median follow-up of nearly five years (56.2 months), a 32 percent reduction in the risk of death was observed in the D-Rd treatment arm vs. Rd arm.1 Median OS was not reached in either arm [hazard ratio (HR): 0.68, 95 percent confidence interval (CI),
New Phase 3 Study Results Show IMBRUVICA ® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia12.6.2021 09:00:00 CEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced primary results from the pivotal Phase 3 GLOW study (NCT03462719) evaluating fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax (I+V) compared to chlorambucil plus obinutuzumab (Clb+O) for first-line treatment of elderly or unfit patients with chronic lymphocytic leukaemia (CLL). The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O as first-line treatment of CLL; the study also showed improved duration of remission and significantly improved depth of remission.1 With I+V, undetectable minimal residual disease (uMRD) in peripheral blood (PB) was sustained by 85 percent of patients one year after end of treatment.1 The safety and tolerability profile of I+V was consistent with CLL treatment in an older population with comorbidities.1 These data were featured in the European Hematology Association (EHA) 2021 Virtual Press Briefing an
Alluzience ® , the first ready-to-use BoNT-A neuromodulator, receives positive decision for use in Europe11.6.2021 11:53:00 CEST | Press release
Galderma today announced that Alluzience® has completed its European decentralized procedure resulting in a positive decision for the first ready-to-use neuromodulator, a wrinkle relaxing injection, in Europe. National approvals will now take place across the region in line with local processes in each country. Designed for precision, Alluzience® is a liquid form of botulinum toxin type A intended for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows), when the severity of these lines has an important psychological impact on the patient.1 "The introduction of Alluzience® marks a new era in treatment innovation for upper facial lines in Europe. Like many aspects of physical appearance, glabellar lines can have a significant impact on patients’ confidence and wellbeing. I’ve heard first-hand that the transition to living and working in a virtual world has only exacerbated these issues. As
Secure Communities Forum: Behavioural Insights Can Assist Governments in the Post-Pandemic World11.6.2021 10:15:00 CEST | Press release
The Secure Communities Forum, a global collaboration of security professionals, has convened a leading panel of experts to discuss how behavioural science can impact positive social cohesion, build on the concept of positive citizenship, and encourage positive individual behaviours. The virtual event was attended by 134 people from 18 countries. The Secure Communities Forum convened the webinar in response to the ongoing Covid-19 pandemic. Governments and law enforcement agencies have used behavioural science to encourage adherence to public health measures like social distancing and mask-wearing. Lindsay Juarez, Director at Irrational Labs, USA, opened the session, offering the view that we assume humans are rational, which is not the case. She said: “Behavioural science is about setting people up for success and breaking through the noise. Information isn't enough to change behaviour, the decision-making context matters. “People don’t always act in their own long-term best interests,
Luxembourg’s Supercomputer MeluXina is Operational11.6.2021 09:18:00 CEST | Press release
Luxembourg’s high performance computer MeluXina was officially launched on June 7 putting the country on the global map of computer super powers. MeluXina is capable of executing more than 10 Petaflops, the equivalent of 10 million billion calculations per second, which will rank it among the world’s top 50 supercomputers. The petascale computer is powered by green energy and is part-funded under the European High Performance Computing Joint Undertaking. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210611005115/en/ Minister of State Xavier Bettel; His Royal Highness Henri, Grand Duke of Luxembourg; Minister of the Economy Franz Fayot; EuroHPC Joint Undertaking Executive Director Anders Jensen (Photo: Business Wire) In a series of 8 high-performance computers in the EU, MeluXina joins Vega, another petascale supercomputer located in Slovenia, as the first EuroHPC machines to go live. Its innovative modular architecture allo