EMD Serono Announces New Data Strengthening Evidence for Continued Safe and Effective MAVENCLAD® Use During the COVID-19 Pandemic

ROCKLAND, Mass.–(BUSINESS WIRE)–EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced a new analysis from the MAGNIFY-MS sub-study showing a specific immune repopulation pattern in patients with relapsing multiple sclerosis (RMS) treated with MAVENCLAD® (cladribine) tablets, which may contribute to their ability to fight infections and develop protective antibodies from vaccines. The data were presented at the 2021 American Academy of Neurology (AAN) Annual Meeting that was held virtually April 17 – 22, 2021.

n the MAGNIFY-MS study, reduction of memory B cells occurred as early as one month after MAVENCLAD initiation with lowest levels sustained for up to 12 months, while naïve B cells, which are typically required for the generation of antibody responses following vaccination, began recovering immediately. Previously shared data from MAGNIFY-MS indicated that patients receiving MAVENCLAD are able to mount responses to influenza and varicella zoster vaccines, irrespective of lymphocyte count.

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In the U.S., the MAVENCLAD label states that all immunizations should be administered according to immunization guidelines prior to starting MAVENCLAD.

“The findings presented at AAN further our understanding of how MAVENCLAD impacts the immune system, and how it may exert a therapeutic effect in patients with multiple sclerosis while repopulating cells which support immune responses,” said Heinz Wiendl, MD, Department of Neurology with Institute of Translational Neurology, University of Muenster, Germany. “These important data indicate that in addition to addressing MS relapses and progression, patients treated with MAVENCLAD may be able to simultaneously mount a proper vaccine response – a particularly important finding at this time.”

In addition, a recent independent study conducted by Anat Achiron, MD, PhD, FAAN and colleagues, The Multiple Sclerosis Center at Sheba Medical Centre and Sackler School of Medicine Tel Aviv University, Israel, and recently published in Therapeutic Advances in Neurological Disorders, shows that patients who have taken MAVENCLAD were able to generate COVID-19 antibodies following the mRNA vaccine from Pfizer/BioNTech administered 4.4 months after last MAVENCLAD dosing. The observational analysis showed that all 23 relapsing-remitting MS patients treated with MAVENCLAD who received the Pfizer/BioNTech mRNA vaccine developed a protective SARS-COV-2 IgG antibody response [antibody titer >1.1 is considered positive; median=7.0], which was similar to the comparison group of MS patients not receiving any immunomodulatory treatments and healthy subjects. Humoral response to the COVID-19 vaccine was independent of lymphocyte count. No unexpected safety findings post first and second dose of Pfizer/BioNTech COVID-19 vaccination were identified in MS patients, according to another recent publication in the Multiple Sclerosis Journal.

“Bringing MAVENCLAD-treated patients into a state where they can live their lives as normally as possible during a global pandemic is of utmost importance to us,” said Danny Bar-Zohar, MD, Global Head of Development for the Healthcare business sector of Merck KGaA, Darmstadt, Germany. “Beyond the convenient oral dosing schedule, proven efficacy, and well-characterized safety profile of MAVENCLAD, newly generated data now show encouraging initial evidence for these patients’ ability to generate adequate antibody response to COVID-19 vaccination, which is so important for patients.”

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