Biogen Idec receives FDA approval for multiple sclerosis, Crohn’s disease treatment

CAMBRIDGE, Mass. The Food and Drug Administration has given approval to a drug for treating multiple sclerosis and Crohn’s disease.

Biogen Idec announced Thursday that the FDA had approved Tysabri (natalizumab), which already has approval in more than 40 countries as a treatment for moderate to severe Crohn’s disease and relapsing forms of multiple sclerosis. Biogen Idec co-markets the drug with Ireland-based Elan Corp.

Biogen Idec will use a high titer process for which it received approval in the European Union in December to manufacture the drug in higher quantities at its plant in Research Triangle Park, N.C.

“Developing this high titer process is another example of our world-class expertise and leadership in biologics manufacturing,” Biogen Idec COO Bob Hamm said. “We expect this new process to result in about a four-fold increase in yield.”