Business Wire

New Real-World Data Support Long-Term Efficacy and Safety Profile of MAVENCLAD®

Share

Merck, a leading science and technology company, today announced the presentation of new data for MAVENCLAD® (cladribine tablets), which further characterise the long-term efficacy and safety profile. These data are being shared at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place from 11–13 September, 2019, in Stockholm, Sweden.

“Our commitment to further understand the long-term efficacy and safety of MAVENCLAD goes beyond the safety profile seen in its clinical development programme, which includes up to 10 years of safety follow-up in some patients,” said Luciano Rossetti, Head of Global Research & Development for the biopharma business of Merck. “The data we are presenting at ECTRIMS 2019 exemplify this. They include key insights from real-world follow-up of patients from our clinical trials and the post-approval setting for MAVENCLAD, further validating it as an important treatment option available to patients in 69 countries worldwide.”

Results from a post hoc analysis (EP1573) evaluating five-year disease stability demonstrated sustained efficacy of cladribine tablets on disability progression, as measured by the Expanded Disability Status Scale (EDSS). According to study findings, 75% of patients showed stable or improved EDSS at five years post-treatment. The exploratory analysis was based on patients treated with cladribine tablets in CLARITY and then placebo in CLARITY Extension, with at least one post-baseline EDSS measurement.

Results were presented from a retrospective analysis (P617) of real-world follow-up data from an Italian multiple sclerosis (MS) registry, consisting of patients with clinically isolated syndrome or relapsing forms of MS who received at least one course of MAVENCLAD in the original clinical trial programme. At five years after receiving the last dose of MAVENCLAD, nearly two-thirds of patients (64%) had no disability progression and more than half of the patients (57%) were free of relapse.

“These data show us that MAVENCLAD continues to display sustained efficacy in a majority of patients at five years after starting treatment and that these results are consistent with data we are seeing from real-world experience,” said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry. “As a neurologist, this is important for me to see, as it shows that findings from the clinical development programme of MAVENCLAD will be borne out in clinical practice.”

In addition, final results (P1390) from the PREMIERE safety registry allowed for a thorough characterisation of the long-term safety profile of MAVENCLAD and showed no new safety findings. Furthermore, post-marketing data in the first 8,419 patients treated with MAVENCLAD worldwide were consistent with the safety profile seen in the MAVENCLAD clinical development programme, with no increase in incidence of adverse events from original clinical programme findings.

*About MAVENCLAD®
MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in 69 countries, including Canada, Australia and the U.S. Refer to the respective prescribing information for further details.

The clinical development programme for cladribine tablets includes:

  • The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients with RRMS.
  • The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4.
  • The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the efficacy and safety of cladribine tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS).
  • The ONWARD (Oral Cladribine Added ON to Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to evaluate the safety and tolerability of adding cladribine tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
  • PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.

In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.

About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

Merck in Neurology and Immunology
Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company's current MS portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

The company’s robust immunology pipeline focuses on discovering new therapies that have the potential to modulate key pathogenic mechanisms in chronic diseases such as MS, systemic lupus erythematosus (SLE) and forms of arthritis, including rheumatoid arthritis (RA) and osteoarthritis (OA).

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck
Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2018, Merck generated sales of € 14.8 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials.

Contact information

Tone Brauti Fritzen
tone-brauti.fritzen@merckgroup.com
+49 151 1454 2694

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Takeda Named Global Top 100 Most Sustainable Corporation for Fifth Year Running21.1.2020 05:00:00 CETPress release

Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) (“Takeda”) is proud to be named in the Corporate Knights Global 100 Most Sustainable Corporations in the World (Global 100) for the fifth consecutive year. Corporate Knights assesses more than 7,300 companies against 21 key performance indicators. It uses these indicators to determine the top 1% most sustainable companies in the world, which are announced annually at the World Economic Forum in Davos, Switzerland. “Building sustainable value is a fundamental part of the way we do business at Takeda, and we are proud to be recognized as a global leader in sustainability,” said Christophe Weber, President and CEO. “This recognition by Corporate Knights is a testament to the strong foundation Takeda has laid and the progress we have already achieved. We remain steadfast in our commitment to realizing Better Health and a Brighter Future for all.” Corporate Knights highlighted Takeda’s performance in the following areas: Significan

Alibaba Cloud Named First Public Cloud Vendor in the World to Obtain Trusted Partner Network (TPN) Certification21.1.2020 02:00:00 CETPress release

Alibaba Cloud, the data intelligence backbone of Alibaba Group, has today announced that it is the first public cloud vendor in the world to obtain the prestigious Trusted Partner Network (TPN) certification, an achievement that validates the entertainment industry’s confidence in its robust security and trustworthiness as a cloud service provider. With viewing consumption habits changing rapidly, broadcast platforms constantly evolving and new production techniques emerging globally, Alibaba Cloud is successfully helping the entertainment industry to revolutionise how it works in order to respond to and embrace these changing dynamics by offering a highly secure, dependable, flexible and scalable cloud-based platform. The TPN is a joint venture between two major entertainment industry associations; the Motion Picture Association of America (MPAA) and the Content Delivery & Security Association (CDSA). The TPN's goal is to help companies to ensure content security, prevent leaks, breac

Logitech Delivers Record Sales and Profitability in Holiday Quarter21.1.2020 02:00:00 CETPress release

Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the third quarter of Fiscal Year 2020. Q3 sales were $903 million, up 4 percent in US dollars and 5 percent in constant currency, compared to Q3 of the prior year. Q3 GAAP operating income grew 4 percent to $129 million, compared to $123 million in the same quarter a year ago. Q3 GAAP earnings per share (EPS) grew 3 percent to $0.69, compared to $0.67 in the same quarter a year ago. Q3 non-GAAP operating income grew 6 percent to $152 million, compared to $143 million in the same quarter a year ago. Q3 non-GAAP EPS grew 6 percent to $0.84, compared to $0.79 in the same quarter a year ago. Cash flow from operations was $181 million, compared to $176 million in the same period a year ago. “We delivered our biggest quarter in sales and profit in company history, topping $900 million in quarterly sales for the first time ever,” said Bracken Darrell, Logitech president and chief executive officer. “Our th

HD-PLC Innovates IoT World21.1.2020 01:00:00 CETPress release

In Japan, the High-definition Power Line Communication (HD-PLC) technology has been mostly used in PLC adapters and communication equipment so far. One major reason was the interpretation of the “Ministerial Order to Provide Technical Standards for Electrical Appliances and Materials” which applied to the integration of HD-PLC into home electric appliances and housing equipment. Recently, the efforts of the involved parties have been rewarded by the Notice issued on December 25, 2019 by the Ministry of Economy, Trade and Industry (METI) that partially revised the interpretation of the Ministerial Order. HD-PLC can now be integrated in home appliances and housing equipment. The main advantages of HD-PLC over wireless technologies include an easy setup of communication networks, a high level of security, and low power consumption. Additionally, HD-PLC can be used on power lines, coaxial cables, telephone lines, and other existing lines which not only enables the deployment of networks in

Morris Group of Companies Announces Solicitation for Offers21.1.2020 00:13:00 CETPress release

TAKE NOTICE THAT the Court of Queen’s Bench for Saskatchewan (the “Court”) granted an Order to 101098672 Saskatchewan Ltd., Morris Industries Ltd., Morris Sales and Service Ltd., Contour Realty Inc., and Morris Industries (USA) Inc. (collectively “Morris Group” or the “Companies”) extending their stay of proceedings under the Companies’ Creditors Arrangement Act (the “CCAA”) to March 27, 2020 (the “Stay Extension”), enabling the Companies to continue with their efforts to restructure their business and financial affairs, including obtaining Court approval to conduct a Sale and Investment Solicitation Process (the “SISP”). Pursuant to the SISP, Alvarez & Marsal Canada Inc., acting in its capacity as the court appointed Monitor of the Morris Group and not in its personal or corporate capacity (the “Monitor”) is soliciting proposals from prospective strategic and financial parties to acquire the business of, or to invest in the Morris Group. The Morris Group primarily carries on business

European Commission Approves Darzalex®▼ (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible20.1.2020 18:43:00 CETPress release

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for Darzalex® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). This approval is based on results from Part one of the Phase 3 CASSIOPEIA (MMY3006) study, published in The Lancet 5 in June 2019 and presented at the 2019 American Society of Clinical Oncology (ASCO) Meeting. “The effectiveness of first-line treatment is critical to maximise time until relapse. So, we asked ourselves, can we improve the standard of care that is bortezomib, thalidomide and dexamethasone (VTd) to provide patients with valuable extra time?” said Philippe Moreau, M.D., principal investigator and Head of the Haematology Department at the University Hospital of Nantes, France. “The CASSIOPEIA study answered that