Merck Serono receives first approval for Cladribine Tablets

Merck Serono has announced that it has been granted regulatory approval in Russia for the sale of Cladribine Tablets as a treatment for multiple sclerosis (MS).

The approval was granted by Russian regulators on the back of positive findings from a phase III clinical trial and will allow the pharmaceutical company to launch the new therapy in the region in early 2011.

It represents the first ever global approval for an oral disease-modifying therapy for MS sufferers, with Merck Serono having also submitted applications for the drug in 40 other nations, including in the US and EU.

Merck Serono expressed confidence that this first approval will pave the way for other positive regulatory rulings in the “near future”.

Elmar Schnee, president of Merck Serono, added: “This is an important milestone reinforcing Merck Serono’s leadership position and ongoing commitment to fight against the devastating disease of multiple sclerosis.”

Earlier this month, Merck Serono published a new study which shows the growing importance of KRAS biomarker testing in treating metastatic colorectal cancer, a trend which has led to an increase in the use of the company’s drug Erbitux.