The Wall Street Journal-20080115-Tysabri Cleared to Treat Crohn-s Disease
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Tysabri Cleared to Treat Crohn's Disease
WASHINGTON -- The U.S. Food and Drug Administration approved Tysabri for use in certain patients with Crohn's disease.
Tysabri, sold jointly by Elan Corp. and Biogen Idec Corp., was previously approved in 2004 as a treatment for multiple sclerosis and is available under a restricted distribution system designed to monitor patients for a rare brain infection.
Tysabri is approved for patients with moderate-to-severe Crohn's disease who have failed or cannot tolerate other treatments including Johnson & Johnson's Remicade and Abbott Laboratories' Humira.
Biogen Idec and Elan said Tysabri should be available to Crohn's patients by the end of next month. The companies said they needed to finish implementing a risk-management plan for the drug.
Similar to a program governing the use of Tysabri in MS patients, the drug will be prescribed, distributed and infused only by prescribers, infusion centers and pharmacies registered with the program. Patients must also participate in the program and will be monitored for the development of side effects, including a brain infection known as progressive multifocal leukoencephalopathy.
Joyce Korvick, the FDA's deputy director of its gastroenterology division, said patients prescribed Tysabri for Crohn's disease who don't show improvement after three months should be taken off of the drug, and patients should also taper down and end steroid treatment by six months after starting treatment.
Tysabri was pulled from the market in 2005 after three patients in clinical trials contracted PML, and two patients died. Two patients were also taking another Biogen drug for MS, Avonex. However, the FDA allowed the drug to return to the market in 2006 with a risk- management program.
Crohn's disease is a chronic, progressive disease marked by inflammation of the bowel. The condition often causes abdominal pain and bleeding and can require surgery. About 600,000 Americans have the disease.
In July, the FDA's gastrointestinal drug and drug safety advisory committees recommended the agency approve the drug under certain conditions including a requirement that Biogen and Elan keep studying the drug in Crohn's patients. In October, the FDA delayed a decision on Tysabri until this month. So far, European regulators have declined to approve Tysabri for use in Crohn's patients.
This month, Biogen Idec said more than 21,000 patients were using Tysabri, and so far there haven't been any additional reports of PML. However, the FDA and the companies have said they expect cases of PML to crop up over time.
