The Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to Cladribine tablets as a treatment of relapsing-remitting multiple sclerosis (RRMS).
Cladribine tablets are an oral formulation of Merck KgaA’s cladribine, an investigational treatment for patients with RRMS – a chronic, inflammatory condition of the central nervous system.
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A Phase III trial involving 1,326 patients with RRMS showed that short-course treatment with Cladribine tablets significantly reduced relapse rates.
The study also demonstrated that the oral treatment reduced risk of disability progression and MRI measures of disease activity at 96 weeks.
Merck KgaA will launch the drug in Russia in early 2011 under the trade name Movectro.
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