FDA Accepts File for Merck Potential Treatment for Relapsing MS

– Cladribine tablets is an investigational oral therapy with proposed dosing of a maximum of 20 days over two years with no additional dosing required in years 3 and 4

– The New Drug Application includes close to 12,000 patient years of data and up to 10 years of safety data in some patients

– Cladribine tablets is approved as MAVENCLAD(R) in 38 countries

EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis (MS) has been accepted for filing by the U.S. Food and Drug Administration (FDA).

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