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Merck KGaA Announces Presentation Of Data For Cladribine Tablets

Merck KGaA (MKGAY.PK) announced the presentation of new data for cladribine tablets at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis or 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 cladribine tablets and reaffirm the 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 or TEAE profile associated with cladribine tablets in patients with relapsing MS or RMS was confirmed, with no new safety findings.

The integrated analysis is based on patients followed for up to 10 years[1] (923 patients received cladribine tablets 3.5 mg/kg; 641 patients received placebo). As part of this analysis, an overview of the post-approval safety data from EU approval on August 2017 to July 2018 also showed no new safety or tolerability signals for cladribine tablets.

Adjusted adverse events incidences per 100 patient-years (Adj-AE per 100PY) for those experiencing =1 serious TEAE were 3.88 for cladribine tablets and 3.24 for placebo in the two-year update, versus 4.00 for cladribine tablets and 3.57 for placebo reported previously.

In addition to serious TEAE, Adj-AE per 100PY were also analyzed for serious lymphopenia, serious infection and infestations, serious herpes zoster, serious neoplasm, benign, malignant and unspecified. Results showed no new adverse events for cladribine tablets have been seen since the first approval in Europe last year.

A total of 47 adverse drug reactions were reported from post-approval sources, none of which were new safety findings.

Post hoc analyses of CLARITY EXT show that following 20 days of treatment with cladribine tablets 3.5 mg/kg in Years 1 and 2 annual NEDA-3 status was sustained in patients treated with cladribine tablets 3.5 mg/kg or placebo up to the end of Year 4.There is also an analysis of EDSS, and clinical and MRI outcomes in patients with high disease activity.

A further post hoc analysis of CLARITY data indicated that the relapse and MRI efficacy of cladribine tablets does not appear to be impacted by age, consistent with previous similar analyses. 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 cladribine tablets compared to placebo in both age groups.

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