Tysabri Usage Restrictions Likely To Remain Stable As FDA Considers REMS Modifications
This article was originally published in The Pink Sheet Daily
While the label of Biogen Idec/Elan's multiple sclerosis drug is expected to be changed to reflect a suspected link between JC-virus and the viral brain infection progressive multifocal leukoencephalopathy, that is unlikely to lead to a new contraindication.
You may also be interested in...
Tysabri’s PML Risk Quantified In Revised Label; Can Added Certainty Add Scripts?
Multiple sclerosis and Crohn’s disease patients with anti-JC virus antibodies who have previously taken other immunosuppressants have a 1.1% risk of developing the deadly neurological condition after taking Biogen Idec /Elan’s Tysabri for more than two years.
U.S. Tysabri Labeling Updated With More PML Risk Info But No Reference To JCV Testing
Partners Biogen Idec and Elan had asked both European and U.S. regulators to update the label to include the addition of anti-JC virus antibody status as a risk factor, but so far only the EU has moved toward JCV testing.
Biogen/Elan Submit Applications For Tysabri Label Change Ahead of Schedule
In a bid to solidify Tysabri's place in an increasingly competitive market, Biogen/Elan push forward with changes to the multiple sclerosis medicine's label that help define the risk of a rare brain infection.