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