Merck KGaA Submits Application for Cladribine Tablets as Multiple Sclerosis Therapy in Europe

24-Jul-2009 - Germany

Merck KGaA announced today the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Cladribine Tablets, Merck’s proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis (MS). Cladribine Tablets could become the first orally administered disease-modifying therapy available for patients with MS, as all disease-modifying therapies currently approved for the treatment of MS are injectable.

“The submission of Cladribine Tablets to the EMEA brings us closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis,” said Roberto Gradnik, Executive Vice President Commercial Europe of the division Merck Serono.

The MAA submission is supported by results from the CLARITY (CLAdRIbine Tablets Treating MS OrallY) study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in patients with relapsing-remitting MS.

Merck is currently submitting new drug applications for Cladribine Tablets in several other countries, including the United States in the current quarter.

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