MAVENCLAD (Cladribine Tablets) Safety Profile in Multiple Sclerosis (MS) Reaffirmed with up to 10-Years of Follow-up Data
MISSISSAUGA, ON, CNW/ - Merck KGaA Darmstadt, Germany, a leading science and technology company, operating as EMD Serono in North America, today announced the presentation of new data for MAVENCLAD® (cladribine tablets) at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany. The data presented at ECTRIMS 2018 build on the existing real-world and clinical evidence around the safety and efficacy of MAVENCLAD and reaffirm a positive benefit-risk profile of the oral treatment which is taken for a maximum of 20 days over two years.
Based on an integrated analysis of patients from the CLARITY, CLARITY EXT, and ORACLE-MS trials, including two additional years of data from the long-term PREMIERE Registry, the treatment emergent adverse event (TEAE) profile associated with MAVENCLAD in patients with RRMS was confirmed, with no new safety findings. The integrated analysis is based on patients followed for up to 10 yearsi (923 patients received MAVENCLAD [cladribine tablets 3.5 mg/kg]; 641 patients received placebo). As part of this analysis, an overview of post-approval safety data to July 2018 also showed no new safety or tolerability signals for MAVENCLAD.
"In my opinion, we have entered the MS era of immune reconstitution therapies (IRT), which are administered intermittently but have an effect on the disease that lasts much longer than the period of dosing," said Professor Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry. "The new data presented at ECTRIMS indicated that MAVENCLAD delivers sustained efficacy well beyond the dosing regimen with no new safety signals found in the long term."
Post hoc analyses of annual NEDA-3 status was performed in patients treated with cladribine tablets 3.5 mg/kg or placebo up to the end of Year 4 in CLARITY EXT.ii There is also an analysis of the Expanded Disability Status Scale (EDSS), and clinical and MRI outcomes in patients with high disease activity.
A post hoc analysis of CLARITY data indicated that the relapse and MRI efficacy of MAVENCLAD does not appear to be impacted by age, consistent with previous similar analyses.iii Data from this study showed that qualifying relapses were reduced in RMS patients aged below and above 45. With regards to MRI measures, the data showed that the number of cumulative new T1 Gd+ and active T2 lesions at Week 96 was reduced with MAVENCLAD compared to placebo in both age groups.iv
"The data presented at ECTRIMS 2018 highlight our commitment to continuing to understand the extended benefit-risk profile of MEVENCLAD," said Luciano Rossetti, Head of Global R&D for the Biopharma business of Merck KGaA, Darmstadt, Germany. "With more and more patients able to access MAVENCLAD globally, it becomes increasingly important for us to invest in scientific research that further characterizes the therapeutic profile, so patients may optimally benefit."
The clinical development program of MAVENCLAD® in MS comprises more than 12,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of observation in some patients. These clinical trials include the Phase III CLARITY, CLARITY extension and ORACLE MS trials, the Phase II ONWARD trial and the PREMIERE Long-term Safety Registry.
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About Merck KGaA, Darmstadt, Germany
Founded in 1668, Merck KGaA, Darmstadt, Germany is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
SOURCE EMD Serono, Canada