Germany- based Merck has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Cladribine Tablets, an investigational oral formulation of cladribine, for patients with relapsing-remitting multiple sclerosis (MS).
Roberto Gradnik, executive vice president of commercial Europe at Merck Serono, said: “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 and underscores our commitment to provide new options for the management of relapsing-remitting multiple sclerosis. We look forward to working with the EMEA and the European member states’ authorities.”
The MAA submission is supported by results from the CLARITYa study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in patients with relapsing-remitting MS.
Merck will be submitting new drug applications for Cladribine Tablets in several other countries, including the US in the current quarter.