Merck KgaA Files European Marketing Application for Multiple Sclerosis Drug

Merck KGaA has filed a marketing authorization application with the European Medicines Agency for cladribine tablets, the company's proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis.

According to Merck, cladribine tablets could become the first orally administered disease-modifying therapy available for patients with multiple sclerosis (MS), as all disease-modifying therapies currently approved for the treatment of MS are injectable.

The marketing authorization application submission is supported by results from the Clarity 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 US in the current quarter.