Merck KGaA receives approval in Russia for cladribine

Merck KGaA on Monday announced that Russia became the first country to approve cladribine for reducing relapses in patients with relapsing-remitting multiple sclerosis. The company said it expects to begin selling the oral drug, which will be marketed in the country under the brand name Movectro, early next year.

The approval was based on results from the 1326-patient CLARITY(1) study, which demonstrated that short-course treatment with cladribine significantly reduced relapse rates. In addition, patients taking cladribine had a significantly reduced risk of disability progression and MRI measures of disease activity after 96 weeks.

Elmar Schnee, head of Merck Serono said "we expect other regulatory approvals in the near future." In June, the drugmaker resubmitted a US regulatory filing for the drug in this indication after the FDA refused to accept its initial submission.

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