Elan secures restricted Tysabri approval
Irish-based multinational pharmaceutical giant Elan and Nasdaq-quoted Biogen Idec have been given restricted approval by the US Food and Drug Administration (FDA) for the reintroduction of multiple sclerosis drug Tysabri.
Shares in Elan fell by 70% in just one day's trading when the multiple sclerosis 'wonder drug' was withdrawn last year due to major fears about its safety.
The approval allows the use of Tysabri as a standalone treatment for relapsing forms of multiple
sclerosis (MS) to slow the progression of disability and reduce the frequency of clinical relapses.
Before Tysabri is made available, the FDA will review Elan's educational and training materials and the companies (Eland and Biogen) will conduct a process of internal validation of systems based on final FDA requirements and training of internal personnel.
The FDA has stipulated revised labelling on Tysabri with enhanced safety warnings and a risk
management plan designed to inform physicians and patients of the benefits and risks of Tysabri treatment and minimize potential risk of progressive multifocal leukoencephalopathy (PML).
Biogen Idec and Elan voluntarily suspended Tysabri from the US market and all clinical trials in February 2005 based on reports of PML, an opportunistic viral infection of the brain that usually leads to death or severe disability.
The companies anticipate Tysabri will be available in July.
