Tysabri Comeback Continues With Crohn’s Approval

Tysabri’s comeback continued today as the FDA approved the drug to treat moderate to severe Crohn’s disease.

It’s intended for patients who have failed conventional treatments for Crohn’s, or those who can’t tolerate other treatments, Joyce Korvick, deputy director of the FDA’s Division of Gastroenterology Products, said in a press conference today.

In 2004, the FDA approved Tysabri to treat multipe sclerosis. But the drug was pulled from the market in 2005 because of a few case reports that connected it to progressive multifocal leukoencephalopathy, a potentially fatal condition.

In 2006, Tysabri returned to the market under a strict safety program. Since then, no additional cases of PML have been reported. Last summer, the UK regulators approved the drug for MS, and some analysts have predicted it will grow into a blockbuster.

The drug, which is given by IV at infusion centers, will be prescribed under tight safety protocols for patients with Crohn’s, an autoimmune disease in which the body attacks the bowel, causing symptoms such as abdominal pain, bleeding, abscesses and diarrhea. If patients fail to improve after three months on the drug, they must discontinue it.

Biogen Idec and Elan, which co-market the drug, have also agreed to conduct long-term testing of Tysabri.

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