Tysabri Linked to 10th Case of Deadly Brain Infection

Tysabri, the controversial multiple sclerosis drug, has caused a tenth user to develop a life-threatening brain infection, the drug’s maker Biogen Idec Inc. said.

Tysabri has a long history with progressive multifocal leukoencephalopathy (PML), an opportunistic, progressive infection of the brain. Concerns about the link between Tysabri and PML forced the drug off the market in 2005, but it was allowed to returned in July 2006 after stronger warning labels were added to warn patients and physicians about the risks.

Recently, Biogen and Elan Corp Plc – which market Tysabri – have stepped up promotions of the drug. Company officials have said after years of controversy about a link to PML, physicians and patients are becoming more comfortable with Tysabri.

Still, sales of Tysabri are down, as it generated about $227 million in the first three months of 2009 and failed to reach the $246 million projection some analysts expected.

Other Tysabri Developments

Biogen officials recently announced they were finalizing a test that can detect a virus that can cause PML. The idea is that patients could be screened for the JC virus before they are put on Tysabri and identified as being at risk before they begin treatment. The test may be ready by late 2009, officials said.

In April, federal regulators slapped Biogen for misleading on-line advertisements for Tysabri which touted the benefits of the drug without emphasizing the potential risks, including PML.

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