Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.
Merck claimed that the Russian registration was a result of the data from the Clarity study, a placebo-controlled Phase III clinical trial in relapsing-remitting MS completed to date, evaluating Cladribine tablets.
The primary endpoint of the clarity study was reduced relapse rates, while the secondary endpoints were the risk of disability progression, and MRI measures of disease activity at 96 weeks.
Merck has initiated its filings in mid-2009 and, to date has submitted regulatory applications for Cladribine tablets in about 40 countries.
Elmar Schnee, member of the board of Merck KGaA and head of Merck Serono division, said: “This approval for Cladribine tablets means that people with multiple sclerosis in Russia are expected to benefit soon from this oral treatment. We expect other regulatory approvals in the near future.”
Cladribine tablets will be made available in Russia under the trade name Movectro in early 2011.