The Food and Drug Administration has approved Biogen Idec's Tysabri for use in treating Crohn's disease.
The drug, manufactured at the company's Research Triangle Park plant, is currently used to treat multiple sclerosis. Biogen Idec and Elan Corp. of Dublin, Ireland, have a partnership to develop and market the formulation behind Tysabri.
"We are pleased with the FDA's decision to make Tysabri available to Crohn's patients suffering from this chronic, debilitating disease," said Dr. Evan Beckman, senior vice president, Immunology Research and Development for Biogen Idec.
"... There remains a significant unmet need for Crohn's patients who have inadequate responses to, or are unable to tolerate, current Crohn's disease therapies."
New Treatment Type
Biogen Idec's and Elan's studies showed that Tysabri induces an anti-inflammatory response and remission among patients with moderately to severely active Crohn's disease. Crohn's disease affects the gastrointestinal tract, causing pain, diarrhea and bleeding. Tysabri represents a new type of treatment for these symptoms.
"The FDA's approval of Tysabri is an important step forward in the treatment of Crohn's disease," said Dr. Stephen Hanauer, Professor of Medicine and Clinical Pharmacology and Chief of the Section of Gastroenterology at the University of Chicago Pritzker School of Medicine.
"A significant number of patients either fail or cannot tolerate current therapies. The unique mechanism of action of Tysabri affords us a new class of therapy in our fight against this debilitating disease."
Boston-based Biogen Idec established a manufacturing plant in Research Triangle Park in 1995 to produce Avonex, also used to treat multiple sclerosis. The plant is one of the largest cell culture facilities in the world.