Tysabri given label update
The EMA has finished its review of the benefits and risks of taking Biogen Idec and Elan’s multiple sclerosis drug natalizumab (Tysabri) after 23 (14 EU, thereof 1 death) cases of potentially deadly brain infections with the JC virus occured following the reintroduction of the drug in 2006. In January, its Committee for Human Medicinal Products (CHMP) concluded that the benefits of the treatment outweigh the risk of contracting progressive multifocal leukoencephalopathy (PML) in patients with highly relapsing-remitting multiple sclerosis or in those who are non-responsive to beta-interferon treatment. CHMP said that the risk is around one case of PML for every 1,000 patients being treated for two years with the humanised monoclonal antibody drug that targets integrin alpha-4. The CHMP recommended stopping Tysabri treatment in patients suspected of having PML. The CHMP noted that this can put patients at risk of immune reconstitution inflammatory syndrome (IRIS), particularly if techniques to remove the medicine from the body quickly – such as plasma exchange or immunoadsorption – are used. IRIS is a condition where the recovering immune system can trigger the symptoms of infection. Furthermore, the prescribing information for Tysabri must be updated to reflect the fact that the risk of PML increases after two years of treatment. Patients should be fully informed about the risk of PML both by their doctor and in an updated ‘patient alert card’.