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FDA Wants Label Changes for Tysabri

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The U.S. Food & Drug Administration (FDA) is asking the makers of Tysabri to update its safety information after two patients in Europe developed a serious brain infection called progressive multifocal leukoencephalopathy (PML) while undergoing monotherapy with the drug. Tysabri had already been linked to PML when it was used with other drugs, but it was thought that treatment with Tysabri alone – monotherapy – lessened the risk of developing the disorder.

According to the FDA, one of the European patients had been treated with Tysabri for 14 months, while the other received it for 17 months. Both were receiving Tysabri alone, but one of the patients had a history of prior immunosuppressant therapy with azathioprine and beta-interferons, the FDA said.  The drug’s makers, Elan and Biogen Idec, reported the two new PML cases.

PML attacks the brain and central nervous system and is usually fatal. It is caused by a polyomavirus, called the JC virus. The JC virus is often acquired during childhood. Most adults have been infected with the JC virus but do not develop PML. The virus appears to remain inactive until something (such as a weakened immune system) allows it to be reactivated and start to multiply. People with a weakened immune system or people taking drugs that suppress their immune system (immunosuppressants) are most likely to get the disease. Symptoms include vision problems, loss of coordination, and memory loss. Patients who survive the disease are often permanently disabled.

In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the dug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.

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