Merck KGaA has been boosted by the news that regulators in Russia have approved cladribine, its oral treatment for multiple sclerosis.
The Russian Federal Service on Surveillance in Healthcare and Social Development has become the first government agency to grant marketing approval to cladribine, which will be available under the tradename Movectro. The German drugmaker’s Merck Serono unit noted that it will now apply for the listing of cladribine within the Russian State Federal drug reimbursement programme and expects to launch in early 2011.
The approval is based on the two-year Phase III CLARITY trial, which revealed that 43% and 44% of patients with relapsing-remitting MS treated with cladribine, on a total dose of 3.5 mg/kg and 5.25 mg/kg respectively, had absence of disease activity, compared with 16% on placebo. Elmar Schnee, president of Merck Serono, said the green light is an important milestone for the firm and “we expect other regulatory approvals in the near future”.
Gavin Giovannoni of the UK’s Blizard Institute of Cell and Molecular Science and principal investigator of CLARITY, said the approval will “transform the way Russian patients with relapsing-remitting MS and physicians approach therapy options”.He added that “I hope that this new therapeutic option will also be available soon for people living with MS in other countries."
Getting the thumbs-up in Russia could help Merck steal a march on Novartis and its rival oral MS product fingolimod in the eastern European markets. However, the Swiss major is ahead in the USA, after the Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of fingolimod, also known as FTY720, last month.
Also in June, Merck resubmitted cladribine with the FDA, seven months after receiving a 'refuse to file' letter from the agency for the treatment. The Darmstadt-based group is also hoping for a positive response from advisors to the European Medicines Agency in the third quarter.