Elan reintroduces Tysabri
Athlone-headquartered pharmaceutical giant Elan has announced the reintroduction for sale in the US and Europe of multiple sclerosis drug Tysabri.
In Europe, Tysabri has been launched in Germany, Ireland, the UK and Sweden.
The US Food and Drug Administration approved the reintroduction of Tysabri as a standalone treatment for relapsing forms of MS to slow the progression of disability and reduce the frequency of clinical relapses.
Tysabri was withdrawn after it was found to have increased the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.
Three cases of PML occurred in clinical trial patients who were exposed at the same time to immunomodulators (interferon beta in the patients with MS) or had the immume systems compromised due to recent treatment with immunosuppressants.
