Merck Serono gets first approval for oral MS drug, gaining Russian clearance for cladribine, with launch expected early 2011

Biotechnology firm Merck Serono, a division of German drug major Merck KGaA, revealed this morning 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). The product will be available in Russia under the trade name Movectro, with an expected launch early next year. The company will now apply for listing within the Russia's federal drug reimbursement program.

Although Russia is clearly not going to be a major global market, it does mean that Merck has been the first to gain approval for an oral MS treatment. The German drugmaker has recently re-filed for clearance with the US Food and Drug Administration, which had previously issued a complete response notification that delayed the approval process (The Pharma Letter June 8).

One step forward in race for first oral MS product