Europe's CHMP gives negative opinion for Merck KGaA' cladribine in multiple sclerosis; backs Sanofi Pasteur MSD's RotaTeq and GSK's Rotarix

There was a bunch of negative and good news coming out of the European Medicines Agency (EMEA) yesterday, with its Committee for Medicinal Products for Human Use (CHMP) giving the thumbs down for German drug major Merck KGaA’s (FWB: MRK) cladribine for use in the treatment of multiple sclerosis, but supporting the continued use of two flu vaccines, as well as issuing a ban of GlaxoSmithKline’s Avandia (rosiglitazone (see separate story today).

The CHMP 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 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. Merck is in a race to get approval of an oral MS treatment with Swiss drug major Novartis, which earlier gained approval for its Gilenya (fingolimod) in the USA (The Pharma Letter September 22).

“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, head of the Merck Serono division. “With the considerable support of the multiple sclerosis community and backed by the recent approvals in Australia and Russia [TPLs passim], 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,” he added