Stymied in U.S., Merck KGaA wins an approval for cladribine

As Merck KGaA wrestles with FDA regulators over its application for the oral MS drug cladribine, the German pharma company won its first approval for the drug--in Russia.

Merck KGaA's cladribine filing was stiff-armed at the FDA last fall when the agency refused to accept it for review. The pharma company refiled in the U.S. in June. But Russia has already offered its approval, and Merck Serono says it expects more markets to follow in short order.

"This is an important milestone reinforcing Merck Serono's leadership position and ongoing commitment to fight against the devastating disease of multiple sclerosis," says Elmar Schnee, president of Merck Serono.

Cladribine had been in a hot race to the marketplace with Novartis' Gilenia, which was handed a resounding endorsement from a federal expert review panel on its way to an expected approval. A number of big developers, including Sanofi, Teva and Biogen Idec, have been developing new oral MS therapies. MS patients frequently spurn currently available biologics for a range of reasons.  

- here's the Merck Serono release
- here's the story from Reuters