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Merck Announces New Data Supporting Continued Use of MAVENCLAD (Cladribine Tablets) During the COVID-19 Pandemic

Posted in Industry News on 6th May 2021

  • New analysis of 57 patients indicates a specific immune repopulation pattern in people treated with MAVENCLAD (Cladribine Tablets)1 6
  • Additionally, an independent study from Israel showed 23 MAVENCLAD-treated patients receiving COVID-19 vaccine were able to mount antibody response similar to that of non-MS patients and untreated MS patients involved in this study2
  • Updated safety data show MAVENCLAD-treated patients with confirmed or suspected COVID-19 continue to have a disease course similar to the general population3

Merck, a leading science and technology company, has recently 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)1 6. The data was presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, being held virtually 17-22 April 2021.

In the MAGNIFY-MS sub-study, reduction of memory B cells occurred as early as one month after Cladribine Tablet 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 infections or vaccination, began recovering quickly. Previously shared data on a small cohort of 15 patients from the MAGNIFY-MS study indicated that patients receiving Cladribine Tablets are able to mount responses to influenza and varicella zoster vaccines, irrespective of lymphocyte count.4

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 Disorders2, shows that patients who have taken Cladribine Tablets were able to generate COVID-19 antibodies following the mRNA vaccine from Pfizer/BioNTech administered as early as 4.4 months after last Cladribine Tablet dosing. The observational analysis showed that all 23 relapsing-remitting MS patients treated with Cladribine Tablets 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. Similar rates of adverse reactions were seen in the MS population as have been reported within the general population following the Pfizer/BioNTech vaccination against SAR-CoV-2 infection’ according to another recent publication in in the Multiple Sclerosis Journal.5

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

As presented at AAN, and also published in MSaRD3 an updated post-approval safety analysis provided a look at outcomes from cases of COVID-19 in Cladribine tablet-treated patients3. The safety database analysis included cases of confirmed (n=160) or suspected (n=101) COVID-19 in Cladribine Tablet-treated patients. Based on the analysis, the majority of patients had mild to moderate respiratory symptoms and none required mechanical ventilation. Cladribine-treated patients had a similar disease course with COVID-19 compared with the general population who acquired COVID-19.

References:

1 MAVENCLAD® Summary of Product Characteristics.

2 A Achiron et all. Therapeutic Advances in Neurological Disorders 2021: Humoral immune response to COVID-19 mRNA vaccine in patients with multiple sclerosis with high-efficacy disease-modifying therapies.

3 MSaRD. COVID-19 in patients with multiple sclerosis treated with cladribine tablets: An update. April 2021.

4 Analysis of Influenza and Varicella Zoster Virus Vaccine Antibody Titers in Patients with Relapsing Multiple Sclerosis Treated with Cladribine Tablets. Presented at ACTRIMS Forum 2021. 25-27 February 2021.

5 A Achiron et al. Multiple Sclerosis Journal: COVID-19 vaccination in patients with multiple sclerosis: What we have learnt by February 2021. April 2021.

6 Weindl et al. Characterization of Peripheral Immune Cell Dynamics and Repopulation Patterns in the First 12 Months of Cladribine Tablets Treatment: MAGNIFY-MS. April 2021.