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Tuesday, July 19, 2016

European Medicines Agency (EMA) accepts Merck’s MAA for cladribine tablets in multiple sclerosis


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July 18, 2016

German science and technology major Merck KGaA (MRK: DE) today said that the European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) of the investigational product cladribine tablets for the treatment of relapsing-remitting multiple sclerosis (MS).
"Our submission of the Marketing Authorization Application for Cladribine Tablets demonstrates Merck's continued commitment to fighting the devastating disease of multiple sclerosis," said Luciano Rossetti, head of global R&D for the Biopharma business of Merck, adding: "Although there are multiple therapies available for relapsing-remitting MS, there is still a significant unmet medical need with a focus on efficacy, dosing, durability and safety. 
We believe that Cladribine Tablets, if approved, would have a first-of-its-kind dosing regimen and serve as an important therapeutic option for patients with relapsing-remitting MS."

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