Table 4 Key events surrounding withdrawal and reintroduction of Tysabri
From: Halo and spillover effect illustrations for selected beneficial medical devices and drugs
Product | Year | Event |
|---|---|---|
Tysabri | 2004 | FDA approves Tysabri (natalizumab) for relapsing-remitting Multiple Sclerosis (RRMS) |
2004 | Biogen reports 3 cases, 1 fatality, of progressive multifocal leukoencephalopathy (PML) | |
2005 | Tysabri withdrawn from the market | |
2006 | Clinical trial participants tested for PML; safety data gathered and reviewed by drug sponsor and FDA | |
2006 | FDA studies evidence, recommends Tysabri reintroduced via restricted distribution program “TOUCH” | |
Post-2006 | Analyses of TOUCH data, clinical trial data, and continued research help clarify risk of PML; Health care providers have risk model to quantify and rank vulnerability to PML for patients | |
Post-2006 | Physicians and patients know more about the risk of PML to Tysabri; The number of patients on Tysabri remains well short of expectations. |