No to Merck's KGaA MAA for MS Cladribine Tablets

The Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a negative opinion regarding Merck KGaA marketing authorization application for Cladribine Tablets as a treatment for relapsing-remitting multiple sclerosis (MS).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion regarding Merck KGaA 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 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, Member of the Executive Board and He