Posted by Michael Wonder on 18 Jul 2016
Merck receives European Medicines Agency acceptance for review of marketing authorization application for cladribine tablets
18 July 2016 - Merck today announced that the EMA has accepted for review the marketing authorisation application of the investigational product cladribine tablets for the treatment of relapsing-remitting multiple sclerosis.
The matrketing authorisation application submission includes data from three Phase III studies, CLARITY, CLARITY EXTENSION and ORACLE MS, and the Phase II ONWARD study. In these trials, cladribine tablets showed significantly reduced relapse rates, risk of disability progression and development of new multiple sclerosis lesions, as detected by MRI, versus placebo in patients with relapsing-remitting multiple sclerosis. Together with interim long-term follow-up data from the prospective registry, PREMIERE, the new application also includes follow-up consisting of over 10,000 patient years of exposure in total, with follow-up in some patients exceeding eight years.
