Merck, a leading science and technology company, announced the presentation of new data for MAVENCLAD® (cladribine tablets), which further characterise the long-term efficacy and safety profile.
Results from a post hoc analysis evaluating five-year disease stability demonstrated sustained efficacy of cladribine tablets on disability progression, as measured by the Expanded Disability Status Scale (EDSS). According to study findings, 75% of patients showed stable or improved EDSS at five years post-treatment. The exploratory analysis was based on patients treated with cladribine tablets in CLARITY and then placebo in CLARITY Extension, with at least one post-baseline EDSS measurement.
Results were presented from a retrospective analysis of real-world follow-up data from an Italian multiple sclerosis (MS) registry, consisting of patients with clinically isolated syndrome or relapsing forms of MS who received at least one course of MAVENCLAD in the original clinical trial programme. At five years after receiving the last dose of MAVENCLAD, nearly two-thirds of patients (64%) had no disability progression and more than half of the patients (57%) were free of relapse.
In addition, final results from the PREMIERE safety registry allowed for a thorough characterisation of the long-term safety profile of MAVENCLAD and showed no new safety findings. Furthermore, post-marketing data in the first 8,419 patients treated with MAVENCLAD worldwide were consistent with the safety profile seen in the MAVENCLAD clinical development programme, with no increase in incidence of adverse events from original clinical programme findings.
MAVENCLAD® is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD® for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD® has since then been approved in 69 countries, including Canada, Australia and the U.S. Refer to the respective prescribing information for further details.
MAVENCLAD is provided as 10 mg tablets for oral use. Each MAVENCLAD 10 mg tablet contains cladribine as an active ingredient and hydroxypropyl betadex, magnesium stearate, and sorbitol as inactive ingredients.