22 June 2017 - Cladribine tablets is the first and only investigational medicinal product to have shown a sustained 4 years of disease control with a maximum of 20 days of oral treatment over 2 years in clinical trials.

Merck today announced that the CHMP of the EMA has issued a positive opinion for approval of cladribine tablets (proposed trade name Mavenclad) for the treatment of relapsing forms of multiple sclerosis (RMS) in patients with high disease activity.

The CHMP positive opinion is based on more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients. The clinical development program included data from three Phase III trials, CLARITY, CLARITY EXTENSION and ORACLE MS, the Phase II ONWARD study and long-term follow-up data from the 8-year prospective registry, PREMIERE. The efficacy and safety results of these studies allowed a full characterisation of the benefit-to-risk profile of cladribine tablets.

Read Merck press release