Germany New Real Tender

Merck today announced new interim real-world data on MAVENCLAD cladribine tablets that show patients with relapsing multiple sclerosis RMS experienced a significant improvement in quality-of-life QoL scores after the first course of treatment in Year 1 with MAVENCLAD. Additionally late-breaking real-world MAVENCLAD data evaluating long-term mobility and disability status suggested sustained benefit beyond the last treatment course and a reduced need for a wheelchair or ambulatory device among MAVENCLAD-treated patients. These data were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis ECTRIMS.A new interim analysis from the open-label Phase IV CLARIFY-MS study demonstrated improvements in QoL measures in 426 patients with RMS early in the treatment course Year 1. After completing half the recommended cumulative dose of MAVENCLAD over two years improvements from baseline were observed for physical and mental health composite scores nominal p0.0001 as measured by the Quality of Life-54 questionnaire. Safety data were consistent with the safety profile seen in the MAVENCLAD clinical development program.Those living with MS know the effect of a treatment goes beyond what is shown in MRIs or in bloodwork. Many patients express that the impact on physical and mental well-being is just as important said Prof. Jeannette Lechner-Scott PhD FRACP Senior Staff Specialist in the Department of Neurology and Conjoint Professor at the University of Newcastle Australia. The quality-of-life outcomes from the CLARIFY-MS study support that MAVENCLAD positively impacts these measures early in the treatment course.Also presented were late-breaking final data from the Phase IV CLASSIC-MS a follow-up study which showed that 90.0 of patients with RMS treated with cladribine tablets did not need to use a wheelchair or were not confined to bed i.e. with an Expanded Disability Status Scale 7 after a median follow-up of 10.9 years range 9.3-14.9. Additionally 81.2 of cladribine tablets-treated patients did not require an ambulatory device. CLASSIC-MS investigated the long-term efficacy in 435 patients with RMS 90.6 of whom were exposed to cladribine tablets during the CLARITY and CLARITY Extension trials. The study focused on long-term mobility and disability two areas of importance as MS can cause problems with movement balance and coordination that can worsen over time.An independent study presented by Prof. Adi Vaknin-Dembinsky MD PhD Senior Neurologist Hadassah Medical Center at the Hebrew University Jerusalem Israel evaluated antibody response after a complete course of the PfizerBioNTech mRNA COVID-19 vaccine in healthy controls and patients with MS untreated or treated with MAVENCLAD or interferon beta-1a. Consistent with previously reported data MAVENCLAD-treated patients as well as those treated with interferon beta-1a who received the PfizerBioNTech mRNA COVID-19 vaccine were found to mount a positive serology response AUmL 19 similar to that of healthy controls. Specifically all patients with MS treated with MAVENCLAD n30 had a positive serology response against the spike protein two to three weeks after vaccination mean226.3121.4. In the study the shortest interval between vaccination and the last dose of MAVENCLAD was 12 weeks.The long-term MAVENCLAD outcomes presented at ECTRIMS 2021 suggest the potential to positively impact future mobility and disability status supporting why MAVENCLAD should be considered a disease-modifying therapy of choice for appropriate adult patients living with RMS stated Danny Bar-Zohar MD Global Head of Development for the Healthcare business of Merck. As new strains of COVID-19 push the pandemic onward and guidance recommends booster vaccinations we are encouraged to have new data that continues to show MAVENCLAD-treated patients with RMS who received an mRNA COVID-19 vaccine have a similar antibody response to the general population.