First oral MS treatment approved in Russia
pharmafile | July 12, 2010 | News story | Sales and Marketing | Cladribine, MS, Merck Serono, Movectro
Regulators in Russia have approved Merck Serono’s cladribine, lining up the drug to be the first oral treatment for multiple sclerosis to reach the market.
Cladribine is expected to be launched in the country in 2011 and will be marketed as Movectro for relapsing-remitting multiple sclerosis (RRMS).
“This approval for cladribine tablets means that people with multiple sclerosis in Russia will benefit soon from this effective oral treatment,” said Elmar Schnee, member of the board at Merck KGaA, and head of its Merck Serono division.
“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.”
Professor Alexey Boyko, from the Russian State Medical University in Moscow, said: “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 multiple sclerosis.”
This will be a boost to the German-based pharma company as Merck was forced to re-submit its MS treatment in the US in June after regulator the FDA issued a ‘refuse to file’ letter in January.
Approval in Russia will also allow Merck to steal a march over rival Novartis, whose own oral MS treatment Gilenia (FTY-720) is also currently being considered by the FDA.
Both drugs have shown positive phase III trial results and have been in a race to be the first to bring an oral MS drug to market.
Ben Adams
Related Content
FDA approves Sandoz’s Tyruko biosimilar to treat relapsing forms of MS
Novartis’ Sandoz has announced that the US Food and Drug Administration (FDA) has approved its …
Genentech shares results from phase 3 trial for MS treatment
Genentech has announced positive results from its phase 3 OCARINA II trial which assessed Ocrevus …
NHS England increases access to cladribine tablets for multiple sclerosis patients during pandemic
NHS England has updated the Blueteq requirements for patients with highly active relapsing MS starting …