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ROCKLAND, Mass, February 24, 2022 – EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced new real-world data from the MSBase Registry demonstrating MAVENCLAD® (cladribine) tablets had more favorable relapse outcomes and longer time to switch to another disease modifying therapy (DMT) compared to the oral DMTs fingolimod, dimethyl fumarate (DMF) and teriflunomide in relapsing multiple sclerosis (RMS) patients. A second study, analyzing real-world follow up of clinical trial patients with a first attack suggestive of MS, showed those treated with MAVENCLAD had a lower rate of conversion to clinically definite multiple sclerosis (CDMS), defined by further relapse or disability progression, and a lower risk of relapse than those not exposed to MAVENCLAD. These data will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, taking place February 24-26, 2022.
In this first analysis of its size from the Generating Learnings In MultiPle SclErosis (GLIMPSE) study, data from 633 patients prescribed MAVENCLAD in the MSBase Registry was matched using propensity scores to patients receiving fingolimod (n=1195), DMF (n=912) or teriflunomide (n=735). Results showed the annualized relapse rate (ARR) for patients treated with MAVENCLAD was 0.09 compared to 0.15, 0.15 and 0.17 for fingolimod, DMF and teriflunomide, respectively. Risk of first relapse in MAVENCLAD-treated patients was 40%, 42% and 67% lower than in patients treated with fingolimod, DMF and teriflunomide, respectively. The time to switch rate in patients treated with MAVENCLAD was 4, 7 and 6.5 times lower than fingolimod, DMF and teriflunomide, respectively. The GLIMPSE study was a longitudinal, retrospective analysis of adult patients identified with RMS from the MSBase Registry, an international online registry for neurologists studying MS and other neuro-immunological diseases.
“It is important in a lifelong disease like MS to continue assessing the efficacy and safety of available treatment options in the real world,” said Helmut Butzkueven, MBBS, FRACP, PhD, Department of Neuroscience, Central Clinical School, Monash University, Melbourne. “This is where the MSBase Registry, using standardized data records from over 79,000 people with MS around the world, can provide information that is not possible to obtain in a randomized clinical trial. This information showed us that in GLIMPSE, MAVENCLAD had better relapse outcomes and longer treatment persistence compared to other oral DMTs, including fingolimod.”
Also being presented are new data from an exploratory Phase IV CLASSIC-MS follow-up of patients (n=227) from the Phase III ORACLE-MS study which suggest early use of cladribine tablets reduced the risk of further relapse or disability progression (CDMS) in patients who experienced a first episode of neurologic attack with characteristics that put them at high risk of CDMS. Over half the patients (53.2%) treated with cladribine tablets remained relapse free compared to 28.2% of those who did not receive cladribine tablets. In patients who received cladribine tablets, 42.9% were diagnosed with CDMS in the median of 9.5 years since their last dose. In patients never treated with cladribine tablets, 70.4% were diagnosed with CDMS.
In ORACLE-MS, patients with a first clinical demyelinating event were randomized to receive cladribine tablets 3.5 mg/kg, cladribine tablets 5.25 mg/kg or placebo. This analysis at the ACTRIMS Forum 2022 investigated the long-term efficacy in patients from the ORACLE-MS trial who had received at least one course of cladribine tablets (68.7%) or placebo (31.3%). Cladribine tablets (5.25 mg/kg) are not approved for any use in any region.
MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery.
Because cladribine is cytotoxic, special handling and disposal instructions should be followed.
MAVENCLAD has been approved in over 80 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information.
IMPORTANT SAFETY INFORMATION
WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
WARNINGS AND PRECAUTIONS
Adverse Reactions: The most common adverse reactions with an incidence of >20% for MAVENCLAD are upper respiratory tract infection, headache, and lymphopenia.
Drug Interactions/Concomitant Medication: Concomitant use of MAVENCLAD with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered.
Avoid concomitant use of certain antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.
Use in Specific Populations: Studies have not been performed in pediatric or elderly patients, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.
Please see the full Prescribing Information, including boxed WARNING for additional information.
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 2.8 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.
EMD Serono, Inc. and Multiple Sclerosis
For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science.
About EMD Serono, Inc.
EMD Serono - the healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada - aspires to create, improve and prolong life for people living with difficult-to-treat conditions like infertility, multiple sclerosis and cancer. The business is imagining the future of healthcare by working to translate the discovery of molecules into potentially meaningful outcomes for people with serious unmet medical needs. EMD Serono’s global roots go back more than 350 years with Merck KGaA, Darmstadt, Germany. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations in Massachusetts. www.emdserono.com.
About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 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 2020, Merck KGaA, Darmstadt, Germany, generated sales of € 17.5 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.