Company’s scientific leadership will be highlighted in 39 abstracts presented across its multiple sclerosis (MS) portfolio

Data on investigational BTK inhibitor evobrutinib demonstrate long-term disease stability in people living with relapsing MS (RMS)

Phase IV study highlights improvement in measures of Quality of Life in people living with RMS after two years of treatment with MAVENCLAD® (cladribine) tablets

ROCKLAND, Mass–(BUSINESS WIRE)–EMD Serono, the Healthcare business sector of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the company will present 39 abstracts at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held October 26-28, 2022 in Amsterdam, the Netherlands. The breadth of data highlights the Company’s scientific leadership in multiple sclerosis (MS) and includes a presentation on a clinical trial with long-term data on Expanded Disability Status Scale (EDSS) scores in people with relapsing MS (RMS) treated with evobrutinib, an investigational agent, as well as new data demonstrating MAVENCLAD® (cladribine) tablets improved Quality of Life (QoL) in people with highly active RMS over two years. Additionally, a two-year follow-up study showed the onset of action on the reduction of MRI lesions with MAVENCLAD being maintained from Month 2 through two years.

“Multiple sclerosis has a profound impact on quality of life and improving this through therapy is often the most important outcome for people living with MS,” said Gavin Giovannoni, Professor of Neurology, Queen Mary University of London. “The data presented at ECTRIMS further substantiate the therapeutic benefit of MAVENCLAD by improving Quality of Life measures over two years, combined with new evidence that the early effect on MRI lesions is maintained over that period.”

In the final analysis of the open-label, single-arm, multicenter, Phase IV CLARIFY-MS study, statistically significant (p≤0.0001) improvements from baseline were observed for Multiple Sclerosis Quality of Life-54 (MSQoL-54) physical and mental health composite scores (mean changes of 4.86 and 4.80, respectively; p<0.0001). Changes in MSQoL-54 composite scores were consistent across treatment naïve and prior disease-modifying treatment (DMT) subgroups. Annualized relapse rate was 0.13 in all patients (0.08 in patients who had not received DMT prior to receiving MAVENCLAD) and median EDSS was unchanged over two years. No new safety concerns emerged.

Also to be presented are new MRI outcomes data from the Phase IV MAGNIFY-MS study, which demonstrated an onset of action from Month 2 with sustained reduction in MRI lesion counts maintained out to two years in people with highly active RMS treated with MAVENCLAD. The proportion of lesion-free patients increased from 47% at baseline to 86.2% at the end of the study (Month 18–24). In the study, MRI lesions at baseline were compared over multiple time periods, from initial screening to Month 24. Over the two years, the benefit:risk profile of MAVENCLAD remained unchanged and in line with observations made during the clinical trial program.

Additionally, updated post-approval safety data will be presented based on an analysis of 56,300 patients who received MAVENCLAD post-approval, representing 95,664 patient-years of experience, as of July 2022. The study found the safety profile of MAVENCLAD is consistent with findings from the clinical development program and the CLARIFY-MS and MAGNIFY-MS studies.

“The breadth of our data at ECTRIMS exemplifies our commitment to pushing forward scientific innovation with the development of evobrutinib, while generating new, meaningful data to demonstrate the safety profile and effectiveness of MAVENCLAD,” said Jan Klatt, Senior Vice President, Head of Development Unit Neurology & Immunology, Merck KGaA, Darmstadt, Germany. “Our goal is to ensure people living with MS, and those who treat them, have the information they need to manage their MS today and in the future.”

Beyond the MAVENCLAD and evobrutinib data presented, EMD Serono will have several Company events, along with additional data from its MS portfolio at ECTRIMS 2022.

Company activities at ECTRIMS 2022:

“Connecting the dots: immune cells and CNS inflammation” co-chaired by Professor Gavin Giovannoni, MBBCh, PhD, FCP (Neurol., SA), FRCP, FRCPath, Blizard Institute, Barts and the London School of Medicine and Dentistry, UK, and Celia Oreja-Guevara, MD, PhD, Hospital Clínico San Carlos, Madrid, Spain (October 26, 2022, 13:15-14:15 CEST)

“New tools for new challenges in multiple sclerosis” chaired by Stephen Krieger, MD, Mount Sinai Hospital, New York, NY, USA (October 28, 2022, 14:15-15:15 CEST)

Product Theater: Early Experience with MAVENCLAD by Ravi Dukkipati, MD, WellSpan Neurology, York, PA, USA

Below is the full list of Company-related abstracts accepted for presentation at ECTRIMS 2022:

Abstract Name

Authors

ID

Presentation Details

MAVENCLAD Poster Presentations

Improvements in Quality of Life Over 2 Years in Patients Treated With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: Final Analysis of CLARIFY-MS

Solari A, Montalban X, Lechner-Scott J, Piehl F, Brochet B, Langdon D, Hupperts R, Selmaj K, Havrdova EK, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, on behalf of the CLARIFY Investigators

P108

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Jeannette Lechner-Scott

Early Onset of Action and Sustained Efficacy of MRI Outcomes during Cladribine Tablets Treatment in Highly Active Relapsing Multiple Sclerosis: Results of the 2-year MAGNIFY-MS Study

De Stefano N, Achiron A, Barkhof F, Chan A, Derfuss T, Hodgkinson S, Leocani L, Montalban X, Prat A, Schmierer K, Sellebjerg F, Vermersch P, Wiendl H, Keller B, Smyk A, Gardner L

P717

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Nicola De Stefano

Updated Post-Approval Safety of Cladribine Tablets in the Treatment of Multiple Sclerosis, With Particular Reference to Liver Safety

Giovannoni G, Leist T, Jack D, Galazka A, Nolting A

P341

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Gavin Giovannoni

High Adherence and Minimal Delays of Year 2 Treatment in People with Multiple Sclerosis Treated with Cladribine Tablets: Results from Multi-Country Patient Support Programmes

Oh J, Ayer M, Alroughani R, Lemieux C, Morgan K, D’Eramo M, Vella T, Boshra A, de Souza S, Verdun di Cantogno E, Sabidó M

P727

Session: 2

Date: October 27, 2022

Time: 17:00 CEST

Presenter: Jiwon Oh

Treatment Emergent Adverse Events Experienced Early and Transiently in the Treatment Course with Cladribine Tablets: Data from the CLEVER Real-World Study

Ziemssen T, Posevitz-Fejfar, Wagner T, Übler S, Richter J, Müller B, Penner I-K

P772

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Talf Ziemssen

Maven4: Phase IV Non-Interventional, Prospective, Spanish Multicenter Study to Evaluate Cladribine Tablets Long Term Effectiveness on Real-World Clinical Practice

Saiz A, Aladro Benito Y, Costa-Frossard F, Sánchez Magro I, Rodríguez Antigüedad A

P774

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Albert Saiz

Cladribine Protects SH-SY5Y Neuron-Like Cells from Oxidative Stress Conditions In Vitro

Eixarch H, Calvo-Barreiro L, Fissolo N, Boschert U, Comabella M, Montalban X, Espejo C

P784

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Herena Eixarch

Real-World Use of Cladribine Tablets (Completion Rates and Treatment Persistence) in Patients With Multiple Sclerosis in England: The CLARENCE Study

Brownlee W, Amin A, Herbert A, Ashton L

P762

Session: 2

Date: October 27, 2022

Time: 17:00 CEST

Presenter: Wallace Brownlee

Decision-making Factors in Patient Choice to Initiate Treatment with Cladribine: A Preliminary Baseline Analysis From the STATURE Study

Allan M, Grech L, Cartwright A, Harding J, Mardan J, O’Maley J, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler E

P304

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Michelle Allan

Assessment of Treatment Satisfaction Across Oral DMTs for Multiple Sclerosis: a Preliminary Baseline Analysis from the STATURE Study.

Grech L, Allan M, Cartwright A, Harding J, Mardan J, O’Maley T, Savickas S, Sharma M, Murambiwa P, Stockle P, Bardsley B, Butler E

EP1086

Session: ePoster

Date: October 26-28, 2022

A Real-World Study of Four-Year Follow Up Study of Patients Treated with Oral Cladribine From 2018-2022

O’Neill DTD, Sharma M, Dong G, Hodgkinson SJ

EP1132

Session: ePoster

Date: October 26-28, 2022

A Study of Activated and Naïve T Regs and B Cell Subsets For 30 Months After the Use of Cladribine

Hodgkinson SJ, O’Neill DTD, Sharma M, Dong G, Verma ND, Al-atiyah R, Hall BM

P704

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Suzanna Hodgkinson

CLADCOMS – CLADribine Tablets Long-Term Control of MS – a Post-Marketing Investigator Driven Study

Fink K, Nilsson P, Alonso L, Sveningsson A, Gunnarsson M, Lange N, Ayad A, Vrethem M, Burman J, Lycke J, Piehl F

EP1060

Session: ePoster

Date: October 26-28, 2022

Clinical Effectiveness and Safety of Cladribine Tablets for Patients Treated at least 12 Months in the Swedish Post-Market Surveillance Study “Immunomodulation and Multiple Sclerosis Epidemiology 10” (IMSE 10)

Rosengren V, Ekström E, Forsberg L, Hillert J, Nilsson P, Dahle C, Svenningsson A, Lycke J, Landtblom A-M, Burman J, Martin C, Sundström, Gunnarsson M, Piehl F, Olsson T

P728

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Linda Forsberg

SARS-CoV2 Exposure Rates and Serological Response of People Living With MS

Longinetti E, Asplund K, Kockum I, Englund S, Burman J, Fink K, Fogdell-Hahn A, Gunnarsson M, Hillert J, Langer-Gould A, Lycke J, Nilsson P, Salzer J, Svenningsson A, Mellergård J, Frisell T, Olsson T, Piehl F

P558

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Elisa Longinetti

COVID-19 Humoral and T-cell Mediated Vaccination Responses in People with Multiple Sclerosis

Vickaryous N, Rios F, Schalk L, Asardag AN, George K, Kang A, Baker D, Giovannoni G, Dobson R

P781

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Nikki Vickaryous

Differences Between Clinical Trials and “Real-World” Use of Disease Modifying Therapies: Insights from the UK OPTIMISE:MS Pharmacovigilance Study

Dobson R, Matthews P, Miller A, Pindoria J, Waddingham E

P763

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Ruth Dobson

Cladribine Treatment Exerts Specific Effects on Memory B Cell Immunoglobulin Repertoires in Multiple Sclerosis Patients

Ruschil C, Gabernet G, Kemmerer CL, Ziemann U, Nahnsen S, Kowarik MC

EP1115

Session: ePoster

Date: October 26-28, 2022

Presenter: Christoph Ruschil

Cladribine Effects on T and B Cell Subsets and T Cell Reactivity in Multiple Sclerosis

Hansen RH, von Essen MR, Mahler MR, Cobanovic S, Binko TS, Sellebjerg F

P697

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Rikke Holm Hansen

Safety and Efficacy of Cladribine Therapy Following a Treatment with Anti-CD20 Compounds in Relapsing Multiple Sclerosis Patients: A Pilot Study

Sacco R, Disanto G, Pravatà E, Gobbi C, Zecca C

EP1068

Session: ePoster

Date: October 26-28, 2022

Evobrutinib Poster Presentations

Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Maintains Lowered Serum Neurofilament Light Chain Levels Over 2.5 Years of Treatment, in Patients With Relapsing Multiple Sclerosis

Kuhle J, Kappos L, Montalban X, Benkert P, Li Y, Thangavelu K, Hyvert Y, Tomic D

EP1021

Session: ePoster

Date: October 26-28, 2022

Presenter: Jens Kuhle

MRI and Clinical Outcomes of Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, in Relapsing Multiple Sclerosis Over 2.5 Years of the Open-label Extension to a Phase II Trial

Vermersch P, Arnold D, Wolinsky JS, Havrdova E, Kinkolykh A, Hyvert Y, Tomic D, Montalban X

P731

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Patrick Vermersch

Evobrutinib Exert a Therapeutic Action on EAE by Increasing the Peripheral and Central Classical Dendritic Cell Number and Maturation

Serrano-Regal MP, Calahorra L, Alonso-García I, Grenningloh R, Boschert U, Haselmayer P, Ortega MC, Machín-Díaz I, Camacho-Toledano C, García-Arocha J, Clemente D

P307

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Mari Paz Serrano-Regal

Evobrutinib, a Bruton’s Tyrosine Kinase Inhibitor, Acts on Microglia: Implications in the Treatment of Progressive Mechanisms in Multiple Sclerosis

Geladaris A, Torke S, Grenningloh R, Boschert U, Brück W, Weber MS

P693

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Anastasia Geladaris

B cells infiltrating the MS brain: from local maturation to targeting by evobrutinib

Bogers L, van Langelaar J, Rijvers L, Engelenburg HJ, Melief M-J, Wierenga-Wolf AF, Rip J, Blok KM, de Vries HE, Hendriks RW, Boschert U, Smolders J, van Luijn MM

P147

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Laurens Bogers

Immune response following mRNA COVID-19 vaccination in patients with multiple sclerosis treated with the Bruton’s tyrosine kinase inhibitor evobrutinib

Bar-Or A, Cross AH, Cunningham A, Hyvert Y, Seitzinger A, Drouin EE, Alexandri N, Tomic D, Montalban X

P1188

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Amit Bar-Or

Rebif® (interferon beta-1a) Subcutaneous Injection Poster Presentations

Exploring the Relationship Between Serum GDF-15 and Disease Stability in Patients with a First Clinical Demyelinating Event Treated with Subcutaneous Interferon β-1a or Placebo in the REFLEX Study

Coray M, Freedman MS, Barkhof F, Comi G, De Stefano N, Kappos L, Enz L, Seitzinger A, Jack D, Kuhle J, Mehling M

EP1027

Session: ePoster

Date: October 26-28, 2022

Presenter: Mali Coray

Evolution of the RebiSmart® Autoinjector Device in Support of Adherence to Subcutaneous Interferon Beta-1a Therapy for Relapsing Multiple Sclerosis

Arnaud L, Keiser M, Henninger E, Piras F, Seitzinger A, Jack D, Le Masne Q

EP1079

Session: ePoster

Date: October 26-28, 2022

Presenter: Dominic Jack

Validation of a Semi-Automated Method to Quantify Lesion Volume Changes in Multiple Sclerosis on 2D Proton Density- Weighted Images Using Subtraction Imaging

Mattiesing RM, Stel S, Mangroe AS, Brouwer I, Versteeg A, van Schijndel RA, Uitdehaag BMJ, Barkhof F, Vrenken H

P634

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Rozemarijn M Mattiesing

Expression of peripheral blood IFN-inducible genes predicts treatment outcome in patients with secondary progressive multiple sclerosis treated with IFN-beta-1a

Gurevich M, Zilkha-Falb R, Menascu S, Magalashvili D, Dolev M, Sonis P, Mandel M, Achiron A

P353

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Michael Gurevich

Non-Product Specific Poster Presentations

DISCOntinuation of disease-modifying therapies in MS (DISCOMS) Extension – Study Design and Baseline Demographics to Date

Engebretson E, Cutter G, Fox R, Kister I, Miller A, Morgan C, Seale R, Corboy JR

EP1089

Session: ePoster

Date: October 26-28, 2022

Expert Opinion on the Use of Contraception in People with Multiple Sclerosis

Hillert J, Bove R, Haddad L, Hellwig K, Houtchens M, Magyari M, Mercki G, Montgomery S, Nappi R, Stenager E, Thompson H, Tulek Z, Verdun di Cantogno E, Simoni M

P080

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Jan Hillert

Single-Cell RNA Sequencing of Peripheral CD8+ T Cells of MS-Discordant Monozygotic Twins Reveals Disease-Associated Alterations In Immune Signaling

Kavaka V, Mutschler L, Eglseer K, Flierl-Hecht A, Kümpfel T, Hohlfeld R, Kerschensteiner M, Gerdes L.A, Beltran E

P159

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Vladyslav Kavaka

Caregiver Burden and Associated Factors Among Caregivers of

Persons with Multiple Sclerosis: Application of a Specific Instrument

Vanotti S, Roman MS, Ferrandina F, Bauer J, Rosa R, Casas Parera I, Saladino ML, Caceres F

EP0864

Session: ePoster

Date: October 26-28, 2022

Presenter: Sandra Vannoti

Evolutionarily Conserved Signatures of Microglia in Health and Disease

Salinas V, Manouchehri N, Hussain R, Stuve O

P131

Session: 1

Date: October 26, 2022

Time: 16:30- 18:30 CEST

Presenter: Victor Salinas

Peripheral Blood Immune Markers Associated With Immunosenescence in Multiple Sclerosis and Healthy Controls

Carpentier Solorio Y, Daigneault A, Tastet O, Clénet M-L, Farzam-kia N, Levert A, Da Cal S, Clément W, Jamann H, Laurent C, Mamane VH, Ouedraogo O, Moratalla AC, Balthazard R, Lahav B, Prat A, Girard J-M, Duquette P, Rousseau M-C, Arbour N, Larochelle C

P545

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Catherine Larochelle

Chemerin Correlates with MS Progression Parameters and Affects Intracellular Metabolism in Human Microglia and Macrophages

Loonstra FC, van der Pol SM, Falize KF, van Heertum T, de Ruiter LR, Schoonheim MM, Killestein J, Uitdehaag BMJ, Kooij G, de Vries HE, Rijnsburger M

P551

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Presenter: Merel Rijnsburger

Amyloid and some tau Proteinopathy are Observed in a Subset of Individuals with Multiple Sclerosis

Taga M, Duquesne L, Lee A, Sigalov A, Peralta Cruz F, De Jager P

P1204

Session: 2

Date: October 27, 2022

Time: 17:00- 19:00 CEST

Non-Product Specific Oral Presentations

Biological Roles of Myeloid Cell Subsets During CNS Inflammation

Manouchehri N, Victor, Hussain RZ, Stuve O

O124

Session: Young Scientific Investigators’ Session 3: Long-term outcomes and safety

Date: October 27, 2022

Time: 15:00- 16:00 CEST

Presenter: Navid Manouchehri

About Evobrutinib

Evobrutinib is an oral, highly selective CNS-penetrant inhibitor of Bruton’s tyrosine kinase (BTK) in clinical development as a potential treatment for relapsing multiple sclerosis (RMS). It is the first BTK inhibitor to demonstrate clinical efficacy in the largest Phase II study with follow-up beyond three years as well as demonstrate an impact on early biomarkers of ongoing central inflammation that correlate with disease progression. Evobrutinib is designed to modulate B cell responses such as proliferation and antibody and cytokine release, as well as modulate macrophage/microglia activation. It significantly reduced SEL volume and levels of blood NfL, markers of ongoing central inflammation and neurodegeneration that predict long-term disability. Evobrutinib was optimized for efficacy through the most comprehensive BTK inhibitor dose-finding study in RMS which demonstrated 75mg twice-daily dosing achieves maximal efficacy across endpoints by sustaining BTK inhibition throughout the dosing interval (>95% BTK occupancy maintained in 98% of patients before next dose). It is currently under clinical investigation and is not approved for any use anywhere in the world.

About MAVENCLAD®

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

Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD

MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant

CONTRAINDICATIONS

Patients with current malignancy.

Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during and for 6 months after the last dose in each treatment course. May cause fetal harm.

Patients with human immunodeficiency virus (HIV).

Patients with active chronic infections (e.g., hepatitis or tuberculosis).

Patients with a history of hypersensitivity to cladribine.

Women intending to breastfeed while taking MAVENCLAD tablets and for 10 days after the last dose.

WARNINGS AND PRECAUTIONS

Malignancies: Treatment with MAVENCLAD may increase the risk of malignancy. After the completion of 2 treatment courses, do not administer additional MAVENCLAD treatment during the next 2 years. In clinical studies, patients who received additional MAVENCLAD treatment within 2 years after the first 2 treatment courses had an increased incidence of malignancy. The risk of malignancy with reinitiating MAVENCLAD more than 2 years after the completion of 2 treatment courses has not been studied. Follow standard cancer screening guidelines in patients treated with MAVENCLAD.

Risk of Teratogenicity: MAVENCLAD may cause fetal harm when administered to pregnant women. In females of reproductive potential, exclude pregnancy before initiation of each treatment course of MAVENCLAD and prevent by the use of effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose of each treatment course. Women who become pregnant during treatment with MAVENCLAD should discontinue treatment.

Lymphopenia: MAVENCLAD causes a dose-dependent reduction in lymphocyte count. In clinical studies, 87% of MAVENCLAD-treated patients experienced lymphopenia. The lowest absolute lymphocyte counts occurred approximately 2 to 3 months after the start of each treatment course and were lower with each additional treatment course. Concomitant use of MAVENCLAD with hematotoxic drugs may increase the risk of adverse reactions because of the additive hematological effects.
Contacts

alice.mcgrail@emdserono.com
Phone: 1-781-681-2886

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