Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that the Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS). Cladribine Tablets will be available in Russia under the trade name Movectro(R).
“This approval for Cladribine Tablets means that people with relapsing-remitting multiple sclerosis in Russia will benefit soon from this effective oral treatment”, said Elmar Schnee, President of Merck Serono. “This is an important milestone reinforcing Merck Serono’s leadership position and ongoing commitment to fight against the devastating disease of multiple sclerosis. We expect other regulatory approvals in the near future.”
Merck Serono initiated its global filings in mid-2009 and, to date has submitted regulatory applications for Cladribine Tablets in about 40 countries.
“The availability of Cladribine Tablets in Russia will represent a key milestone for people with multiple sclerosis as this is the first approval of an orally-administered disease-modifying therapy for relapsing-remitting multiple sclerosis”, said Professor Alexey Boyko, Department of Neurology and Neurosurgery at the Russian State Medical University, Moscow. “This approval is an important step toward optimizing medical care in multiple sclerosis.”
“The approval of Cladribine Tablets will transform the way Russian patients with relapsing-remitting multiple sclerosis and physicians approach therapy options”, said Professor Gavin Giovannoni, Blizard Institute of Cell and Molecular Science, Barts and The London School of Medicine and Dentistry, London, United Kingdom, and principal investigator of the CLARITY study. “I hope that this new therapeutic option will also be available soon for people living with multiple sclerosis in other countries.”
Merck Serono will now apply for the listing of Cladribine Tablets within the Russian State Federal drug reimbursement program. The Company expects to launch Movectro(R) in Russia in early 2011