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EMEA reviews Tysabri after PML increase

The EMEA has provided its latest update on Tysabri-linked cases of progressive multifocal leukoencephalopathy (PML)

The European Medicines Agency (EMEA) has provided its latest update on Tysabri-linked cases of progressive multifocal leukoencephalopathy (PML), the deadly brain infection, bringing the number of cases diagnosed since 2006 to 24. Of these 14 cases have been recorded in the European Union, with two in Switzerland and eight in the United States. Of those 24 patients diagnosed, four have died. 

EMEA's update follows the regulator's announcement last Friday that it had begun a review of the drug considering the number of PML cases diagnosed was up to 23. A total of 10 new cases have emerged in just the past six weeks. 

Tysabri, the top-selling multiple sclerosis drug, was withdrawn just a few months after it hit the market in 2005 when three cases of drug related PML were diagnosed. Patients, however, pleaded for the product's return and it was reintroduced in the US in 2006 under a strict risk-management programme, and under varying levels of restriction and oversight in Europe. In the wake of these latest findings, however, both EMEA and the US Food and Drug Administration (FDA) are considering if they need to take further measures to ensure patient safety.

In a statement to Bloomberg, a Biogen spokeswoman, Jennifer Neiman, said: "The incidence of PML is rare and the rate remains consistent with what was seen in clinical trials and what is described in our current label." Despite these assurances, Biogen Idec's shares fell as much as three per cent following EMEA's review announcement last week.

2nd November 2009


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