FDA approves Tysabri for treatment of Crohn's

WASHINGTON The Food and Drug Administration has approved the multiple sclerosis drug Tysabri, manufactured by Biogen Idec and Elan, to treat moderate to severe cases of Crohn’s disease in patients with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s disease therapies.

Crohn’s disease is a chronic, inflammatory bowel disease that affects both men and women, for which there is no cure. There are more than 1 million people with Crohn’s disease worldwide.

Crohn’s disease patients using the drug must be enrolled in a special restricted distribution program called the Crohn’s Disease–Tysabri Outreach Unified Commitment to Health Prescribing Program. Under CD-TOUCH, health care providers evaluate Crohn’s disease patients after three months of treatment to determine if they have improved on Tysabri. If not, patients should discontinue treatment.

Because of the risks associated with the drug which include anaphylaxis, liver injury and serious herpes infections, patients, prescribers, pharmacies, and infusion centers must all be enrolled in CD-TOUCH and agree to comply with the company’s strict monitoring guidelines. Additionally, they must participate in an extensive educational program designed to inform people about the risks of Tysabri treatment.

“The addition of Tysabri to the treatment options for sufferers of Crohn’s disease is important, but one that carries serious risks,” said Daniel Shames, deputy director of the Office for Drug Evaluation III and director of the Division of Gastroenterology Products for the Center for Drug Evaluation and Research. “Health care providers must carefully monitor patients for these risks. The CD-TOUCH Prescribing Program will aid FDA in monitoring this drug through its life cycle.”