EMA accepts Merck's MAA for cladribine tablets in multiple sclerosis

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."

Back in 2011 Merck wound down its clinical development of cladribine tablets after some regulatory authorities expressed concerns over it. Despite this, several large clinical trials were allowed to complete and additional safety information was also collected in a long-term registry.