: Merck Serono Announces CHMP Opinion for Cladribine Tablets in MS patients in Europe

Merck Serono is Committed to Making Cladribine Tablets Available to MS Patients in Europe and is Evaluating all Options to Gain Approval in the European Union
Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion regarding the marketing authorization application (MAA) for Cladribine Tablets as a treatment for relapsing-remitting multiple sclerosis (MS). The CHMP is of the opinion that based on currently available data the benefits of Cladribine Tablets do not outweigh its risks. Merck Serono is committed to making Cladribine Tablets available to MS patients in Europe and is evaluating all options to gain approval in the European Union, including a potential appeal to request re-examination of the submission by the CHMP, in accordance with the current European regulatory legislation.
"We are disappointed by the CHMP opinion, but remain fully committed to the potential of Cladribine Tablets to meet an unmet medical need as an oral, short-course, disease-modifying drug for multiple sclerosis," said Elmar Schnee, President of Merck Serono. "With the considerable support of the multiple sclerosis community and backed by the recent approvals in Australia and Russia, we will continue to work with the CHMP to address the committee's concerns and pursue a way forward to make Cladribine Tablets available to patients from the European Union."
"Multiple sclerosis is a heterogeneous disease and currently available treatments do not meet the medical needs of all patients with active disease," said Professor Gavin Giovannoni, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, London, United Kingdom, and principal investigator of the CLARITY[1] study. "As a clinician, I hope that a way forward will be found to allow people suffering from this devastating disease to have the option of benefiting from Cladribine Tablets therapy."
Cladribine Tablets were recently approved in Australia and Russia, as a treatment of relapsing-remitting MS, also under the trade name Movectro(R), and are under regulatory review in other countries, including the United States, where the application has been granted Priority Review by the FDA. Cladribine Tablets registration applications are supported by the results from the CLARITY study, the largest placebo-controlled Phase III clinical trial in relapsing-remitting MS completed to date, involving over 1,300 patients with relapsing-remitting multiple sclerosis. Ongoing clinical trials with Cladribine Tablets will continue as planned.